Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309; f) DBM T600612 XPANSE LARGE-L, REF T600612; Demineralized Bone Matrix (DBM) product
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) DBM T600106 XPANSE SMALL-C 6, REF T600106, GTIN 00643169218314, Serial Numbers: A41747-061, A41747-062, A41747-063, A41747-064, A41747-065, A41747-066, A41747-067, A41747-068, A41747-069, A41747-070, A41747-071, A41747-072, A41747-073, A43745-061, A43745-062, A43745-063, A43745-064, A43745-065, A43745-066, A43745-067, A43745-068, A43745-069, A43745-070, A43745-071, A43745-072, A43745-073, A43745-074, A43745-075, A43748-036, A43748-037, A43748-038, A43748-039, A43748-040, A46458-036, A46458-037, A46458-038, A46458-039, A46458-040, A46458-041, A46458-042, A46458-043, A46458-044, A46458-045, A46458-046, A46458-047, A46458-048, A49576-028, A49576-029, A49576-030, A49576-031, A49576-032, A49576-033, A49576-034, A49576-035, A49576-036, A49576-037, A49576-038, A49576-039, A49576-040; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206, GTIN 00643169218352, Serial Numbers: A38618-078, A38618-079, A38618-080, A38618-081, A38618-082, A38618-083, A38618-084, 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A47673-084, A47673-085, A47673-086, A47673-087, A47673-088, A47673-089, A47673-090, A47673-091, A47673-092, A47673-093, A47673-094, A47673-095, A47673-096, A47673-097, A47673-098, A47673-099, A47673-100, A47728-011, A47728-012, A47728-013, A47728-014, A47728-015, A47728-016, A47728-017, A47728-018, A47728-019, A47728-020, A47728-021, A47728-022, A47728-023, A47728-024, A47728-025, A47728-026, A47728-027, A47728-028, A47728-029, A47728-030, A47728-031, A47728-032, A47728-033, A47728-034, A47728-035, A47728-036, A47728-037, A47728-038, A47728-039, A47728-040, A47728-041, A47728-042, A47728-043, A47728-044, A47728-045, A47728-046, A47728-047, A47728-048, A47728-049, A47728-050, A47728-051, A47728-052, A47728-053, A47728-054, A47728-055, A47728-056, A47728-057, A47728-058, A47728-059, A49576-041, A49576-042, A49576-043, A49576-044, A49576-045, A49576-046, A49576-047, A49576-048, A49576-049, A49576-050, A49576-051, A49576-052, A49576-053, A49576-054, A49576-055, A49576-056, A49576-057, A49576-058, A49576-059, A49576-060, A49576-061, A49576-062, A49576-063, A49576-064, A49576-065, A49576-066, A49576-067, A49576-068, A49576-069, A49576-070, A49576-071, A49576-072, A49576-073, A49576-074, A49576-075, A49576-076, A49576-077, A49576-078, A49576-079, A49576-080, A49576-081, A49576-082, A49576-083, A49576-084, A49576-085, A49576-086, A49576-087, A49576-088, A49576-089, A49576-090, A49576-091, A49576-092, A49576-093, A49576-094, A49576-095, A49576-096, A49576-097, A49576-098, A49576-099, A49576-100, A49579-011, A49579-012, A49579-013, A49579-014, A49579-015, A49579-016, A49579-017, A49579-018, A49579-019, A49579-020, A49579-021, A49579-022, A49579-023, A49579-024, A49579-025, A49579-026, A49579-027, A49579-028, A49579-029, A49579-030, A49579-031, A49579-032, A49579-033, A49579-034, A49579-035, A49579-036, A49579-037, A49579-038, A49579-039, A49579-040, A49579-041, A49579-042, A49579-043, A49579-044, A49579-045, A49579-046, A49579-047, A49579-048, A49579-049, A49579-050, A49579-051, A49579-052, A49579-053, A49579-054, A49579-055, A49579-056, A49579-057, A49579-058, A49579-059, A49579-060, A49579-061, A49579-062, A49579-063, A49579-064, A49579-065, A49579-066, A49579-067, A49579-068, A49579-069, A49579-070, A49752-119, A49752-120, A49752-121, A49752-122, A49752-123, A49752-124, A49752-125, A49752-126, A49752-127, A49752-128, A49752-129, A49752-130, A49752-131, A49752-132, A49752-133, A49752-134, A49752-135, A49752-136, A49752-137, A49752-138, A49752-139, A49752-140, A49752-141, A49752-142, A49752-143, A49752-144, A49752-145, A51605-037, A51605-038, A51605-039, A51605-040, A51605-041, A51605-042, A51605-043, A51605-044, A51605-045, A51605-046, A51605-047, A51605-048, A51605-049, A51605-050, A51605-051, A51605-052, A51605-053, A51605-054, A51605-055, A51605-056, A51605-057, A51605-058, A51605-059, A51605-060, A51605-061, A51605-062, A51605-063, A51605-064, A51605-065, A51605-066, A51605-067, A51605-068, A51605-069, A51605-070, A51605-071, A51605-072, A51605-073, A51605-074, A51605-075, A51605-076, A51605-077, A51605-078, A51605-079, A51605-080, A51605-081, A51605-083, A51605-084, A51605-085, A51605-086, A51605-087, A51605-088, A51605-089, A51605-090, A51605-091, A51605-092, A51605-093, A51605-094, A51605-095, A51605-096, A52340-029, A52340-030, A52340-031, A52340-032, A52340-033, A52340-034, A52340-035, A52340-036, A52340-037, A52340-038, A52340-039, A52340-040, A52340-041, A52340-042, A52340-043, A52340-044, A52340-045, A52340-046, A52340-047, A52340-048, A52340-049, A52340-050, A52340-051, A52340-052, A52340-053, A52340-054, A52340-055, A52340-056, A52340-057, A52340-058, A52340-059, A52340-060, A52340-061, A52340-062, A52340-063, A52340-064, A52340-065, A52340-066, A52340-067, A52340-068, A52340-069, A52340-070, A52340-071, A52340-072, A52340-073, A52340-074, A52340-075, A52340-076, A52340-077, A52340-078, A52340-079, A52340-080, A52340-081, A52340-082, A52340-083, A52340-084, A52340-085, A52340-086, A52340-087, A52340-088, A52340-089, A52340-090, A52340-091, A52340-092, A52340-093, A52340-094, A52340-095, A52340-096, A52340-097, A52340-098, A53036-073, A53036-074, A53036-075, A53036-076, A53036-078, A53036-079, A53036-080, A53036-081, A53036-082, A53036-083, A53036-084, A53036-085, A53036-086, A53036-087, A53036-088, A53036-089, A53036-090, A53036-091, A53036-095, A53036-096, A53036-097, A53036-098, A53036-099, A53036-100, A53036-101, A53036-102, A53036-103, A53036-104, A53036-105, A53036-106, A53036-107, A53036-108, A53036-109, A53036-110, A53036-111, A53036-112, A53036-113, A53036-114, A53036-115, A53036-116, A53036-117, A53036-118, A53036-119, A53036-120, A53036-121, A53036-122, A53036-123, A53036-124, A53036-125, A53036-126, A53036-127, A53036-128, A53036-129, A53036-130, A53036-131, A53036-132, A53036-133, A53036-134, A53036-135, A53036-136, A53036-138, A53036-139, A53036-140, A53036-141, A53036-142, A53036-143, A53036-144, A53036-145; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209, GTIN 00643169218376, Serial Numbers: A40169-098, A40169-099, A40169-100, A40169-101, A40169-102, A40169-103, A40169-104, A40169-105, A40169-106, A40169-107, A40169-108, A40169-109, A40169-110, A40169-111, A40169-112, A40169-113, A40169-114, A40169-115, A40169-116, A40169-117, A40169-118, A40169-119, A40169-120, A40169-121, A40169-122, A40169-123, A40169-124, A40169-125, A40169-126, A40169-127, A40169-128, A40169-129, A40169-130, A40169-131, A40169-132, A40169-133, A40169-134, A40169-135, A40169-136, A40169-137, A40169-138, A40169-139, A40169-140, A40169-141, A40169-142, A40734-040, A40734-041, A40734-042, A40734-043, A40734-044, A40734-045, A40734-046, A40734-047, A40734-048, A40734-049, A40734-050, A40734-051, A40734-052, A40734-053, A40734-054, A40734-055, A40734-056, A41315-130, A41315-131, A41315-132, A41315-133, A41315-134, A41315-135, A41315-137, A41315-138, A41315-139, A41315-140, A41315-141, A41315-142, A41315-143, A41315-144, A41315-145, A41315-146, A41315-147, A41315-148, A41315-149, A41315-150, A41315-151, A41315-152, A41315-153, A41315-154, A41315-155, A41315-156, A41315-157, A41315-158, A41315-159, A41315-160, A41315-161, A41315-162, A41315-163, A41315-164, A41315-165, A41315-166, A41315-167, A41315-168, A41315-169, A41479-108, A41479-109, A41479-110, A41479-111, A41479-112, A41479-113, A41479-114, A41479-115, A41479-116, A41479-117, A41479-118, A41479-119, A41479-120, A41479-121, A41479-122, A41479-123, A41479-124, A41479-125, A41479-126, A41479-127, A41479-128, A41479-129, A41479-130, A41479-131, A41479-132, A41479-133, A41479-134, A41479-135, A41479-136, A41479-137, A41479-138, A41479-139, A41479-140, A41479-141, A41479-142, A41479-143, A41479-144, A41479-145, A41479-146, A41479-147, A41479-148, A41479-149, A41479-150, A41479-151, A41479-152, A41479-153, A41479-154, A41479-155, A41479-156, A41479-157, A41479-158, A41479-159, A41479-160, A41479-161, A41479-162, A41479-163, A41479-164, A41479-165, A41479-166, A41479-167, A42964-112, A42964-113, A42964-114, A42964-115, A42964-116, A42964-117, A42964-118, A42964-120, A42964-121, A42964-122, A42964-123, A42964-124, A42964-125, A42964-126, A42964-127, A42964-128, A42964-129, A42964-130, A42964-131, A42964-132, A42964-133, A42964-134, A42964-135, A42964-136, A42964-137, A42964-138, A42964-139, A42964-140, A42964-141, A42964-142, A42964-143, A42964-144, A42964-145, A42964-146, A42964-147, A42964-148, A42964-149, A42964-150, A42964-151, A42964-152, A42964-153, A42964-154, A42964-155, A42964-156, A42964-157, A42964-158, A42964-159, A42964-160, A42964-161, A42964-162, A43287-081, A43287-082, A43287-083, A43287-084, A43287-085, A43287-086, A43287-087, A43287-088, A43287-089, A43287-090, A43287-091, A43287-092, A43287-093, A43287-094, A43287-095, A43287-096, A43299-085, A43299-086, A43299-087, A43299-088, A43299-089, A43299-090, A43299-091, A43299-092, A43299-093, A43299-094, A43299-095, A43299-096, A43299-097, A43299-098, A43299-099, A43299-100, A43299-101, A43299-102, A43299-103, A43299-104, A43299-105, A43299-106, A43299-107, A43299-108, A43299-109, A43299-110, A43299-111, A43299-112, A43299-113, A43748-136, A43748-137, A43748-138, A43748-139, A43748-140, A43748-141, A43748-142, A43748-143, A43748-144, A43748-145, A43748-146, A43748-147, A43748-148, A43748-149, A43748-150, A43748-151, A43748-152, A43748-153, A43748-154, A43748-155, A43748-156, A43748-157, A43748-158, A43748-159, A43748-160, A43748-161, A43748-162, A43748-163, A43748-164, A43748-165, A43748-166, A43748-167, A43748-168, A43748-169, A43748-170, A43748-172, A43748-173, A43748-174, A43748-175, A43748-176, A43748-177, A43748-178, A43748-179, A43748-180, A43748-181, A43748-184, A43748-186, A43748-187, A43748-188, A43748-189, A43748-190, A43748-193, A43748-195, A43748-198, A43748-199, A43748-200, A43748-201, A43748-202, A43748-203, A43748-204, A43748-205, A43748-206, A43748-207, A43748-208, A43748-209, A43748-210, A43748-211, A43748-212, A45739-192, A45739-193, A45739-194, A45739-195, A45739-196, A46844-092, A46844-093, A46844-094, A46844-095, A46844-096, A46844-097, A46844-098, A46844-099, A46844-100, A46844-101, A46844-102, A46844-103, A46844-104, A46844-105, A46844-106, A46844-107, A46844-108, A46844-109, A46844-110, A46844-111, A46844-112, A46844-113, A46844-114, A46844-115, A46844-116, A46844-117, A46844-118, A46844-119, A46844-120, A47673-101, A47673-102, A47673-103, A47673-104, A47673-107, A47673-108, A47673-109, A47673-110, A47673-111, A47673-112, A47673-113, A47673-114, A47673-115, A47673-116, A47673-117, A47673-118, A47673-119, A47673-120, A47673-121, A47673-122, A47673-123, A47673-124, A47673-125, A47673-126, A47673-127, A47673-128, A47673-129, A47673-130, A47673-131, A47673-132, A47673-133, A47673-134, A47673-135, A47673-136, A47673-137, A47673-138, A47673-139, A47673-140, A47673-141, A47673-142, A47673-143, A47673-144, A47673-145, A47673-146, A47673-147, A47673-148, A47673-149, A47673-150, A47673-151, A47673-152, A47673-153, A47673-154, A47673-155, A47673-156, A47673-157, A47673-158, A47673-159, A47673-160, A47673-161, A47673-162, A47673-163, A47673-164, A47673-165, A47673-166, A47673-167, A47673-168, A47673-169, A47673-170, A47673-171, A47673-172, A47728-060, A47728-061, A47728-062, A47728-063, A47728-064, A47728-065, A47728-066, A47728-067, A47728-068, A47728-069, A47728-070, A47728-071, A47728-072, A47728-073, A47728-074, A47728-075, A47728-076, A47728-077, A47728-078, A47728-079, A47728-080, A47728-081, A47728-082, A47728-083, A47728-084, A47728-085, A47728-086, A47728-087, A47728-088, A47728-089, A47728-090, A47728-091, A47728-092, A47728-093, A47728-094, A47728-095, A47728-096, A47728-097, A47728-098, A47728-099, A49576-101, A49576-102, A49576-103, A49576-104, A49576-105, A49576-106, A49576-107, A49576-108, A49576-109, A49576-110, A49576-111, A49576-112, A49576-113, A49576-114, A49576-115, A49576-116, A49576-117, A49576-118, A49576-119, A49576-120, A49576-121, A49576-122, A49576-124, A49576-125, A49576-126, A49576-127, A49576-128, A49576-129, A49576-130, A49576-132, A49576-133, A49576-134, A49576-135, A49576-136, A49579-071, A49579-072, A49579-073, A49579-074, A49579-075, A49579-076, A49579-077, A49579-078, A49579-079, A49579-080, A49579-081, A49579-082, A49579-083, A49579-084, A49579-085, A49579-086, A49579-087, A49579-089, A49579-090, A49579-091, A49579-092, A49579-093, A49579-094, A49579-095, A49579-096, A49579-097, A49579-098, A49579-099, A49579-100, A49752-023, A49752-024, A49752-025, A49752-026, A49752-027, A49752-028, A49752-029, A49752-030, A49752-031, A49752-032, A49752-033, A49752-034, A49752-035, A49752-036, A49752-037, A49752-038, A49752-039, A49752-040, A49752-041, A49752-042, A49752-043, A49752-044, A49752-045, A49752-046, A49752-047, A49752-048, A49752-049, A49752-050, A49752-051, A51605-097, A51605-098, A51605-099, A51605-100, A51605-101, A51605-102, A51605-103, A51605-104, A51605-105, A51605-106, A51605-107, A51605-108, A51605-109, A51605-110, A51605-111, A51605-112, A51605-113, A51605-114, A51605-115, A51605-116, A51605-117, A51605-118, A51605-120, A51605-121, A51605-122, A51605-123, A51605-124, A51605-125, A51605-126, A51605-127, A51605-128, A51605-129, A51605-130, A51605-131, A51605-132, A51605-133, A51605-134, A51605-135, A51605-136, A51605-137, A51605-138, A51605-139, A51605-140, A51605-141, A51605-142, A51605-143, A51605-144, A51605-145, A51605-146, A51605-147, A51605-148, A51605-149, A51605-150, A51605-151, A51605-152, A51605-153, A51605-154, A51605-155, A51605-156, A52340-099, A52340-100, A52340-101, A52340-102, A52340-104, A52340-106, A52340-109, A52340-112, A52340-113, A52340-115, A52340-116, A52340-119, A52340-134, A52340-135, A52340-136, A52340-138, A52340-140, A52340-141, A52340-142, A52340-143, A52340-144, A52340-145, A52340-146, A52340-147, A52340-148, A52340-149, A52340-155, A52340-156, A52340-157, A52340-158, A52340-159, A52340-160, A52340-161, A52340-162, A52340-163, A52340-164, A52340-165, A52340-166, A52340-167, A52340-168, A52340-169, A53036-146, A53036-147; d) DBM T600306 XPANSE LARGE-C 6, REF T600306, GTIN 00643169218390, Serial Numbers: A38618-018, A38618-019, A38618-020, A38618-021, A38618-022, A38618-023, A38618-024, A38618-025, A38618-026, A38618-027, A38618-028, A38618-029, A38618-030, A38618-031, A38618-032, A38618-033, A38618-034, A38618-035, A38618-036, A38618-037, A38618-038, A38618-039, A38618-040, A38618-041, A38618-042, A38618-043, A38618-044, A38618-045, A38618-046, A38618-047, A38618-048, A38618-049, A38618-050, A38618-051, A38618-052, A38618-053, A38618-054, A38618-055, A38618-056, A38618-057, A38618-058, A38618-059, A38618-060, A38618-061, A38618-062, A38618-063, A38618-064, A38618-065, A38618-066, A38618-067, A38618-068, A38618-069, A38618-070, A38618-071, A38618-072, A38618-073, A38618-074, A38618-075, A38618-076, A38618-077, A39566-113, A39566-114, A39566-115, A39566-116, A39566-117, A39566-118, A39566-119, A39566-120, A39566-121, A39566-122, A39566-123, A39566-124, A39566-125, A39566-126, A39566-127, A39566-128, A39566-129, A39566-130, A39566-131, A39566-132, A39566-133, A39566-134, A39566-135, A39566-136, A39566-137, A39566-138, A39566-139, A39566-140, A39566-141, A39566-142, A39566-143, A39566-144, A39566-145, A39566-146, A39566-147, A39566-148, A39566-149, A39566-150, A39566-151, A39566-152, A39566-153, A39566-154, A39566-155, A39566-156, A39566-157, A39566-158, A39566-159, A39566-160, A39566-161, A39566-162, A39566-163, A39566-164, A39566-165, A39566-166, A39566-167, A39566-168, A39566-169, A39566-170, A39566-171, A39566-172, A39566-173, A39566-174, A39566-175, A39566-176, A39566-177, A39566-178, A39566-179, A39566-180, A39566-181, A39566-182, A39566-183, A39566-184, A39566-185, A39566-186, A40105-083, A40105-084, A40105-085, A40105-086, A40105-087, A40105-088, A40105-089, A40105-090, A40105-091, A40105-092, A40105-093, A40105-094, A40105-095, A40105-096, A40105-097, A40105-098, A40105-099, A40105-100, A40105-101, A40105-102, A40105-103, A40105-104, A40105-105, A40105-106, A40105-107, A40105-108, A40105-109, A40105-110, A40105-111, A40105-112, A40105-113, A40105-114, A40105-115, A40105-116, A40105-117, A40105-118, A40105-119, A40105-120, A40105-121, A40105-122, A40105-123, A40105-124, A40105-125, A40105-126, A40105-127, A40105-128, A40105-129, A40105-130, A40105-131, A40169-149, A40169-150, A40169-151, A40169-152, A40169-153, A40169-154, A40169-155, A40169-156, A40169-157, A40169-158, A40169-159, A40169-160, A40169-161, A40169-162, A40169-163, A40169-164, A40169-165, A40169-166, A40169-167, A40169-168, A40169-169, A40169-170, A40169-171, A40169-172, A40169-173, A40169-174, A40169-175, A40169-176, A40169-177, A40169-178, A40169-179, A40169-180, A40169-181, A40169-182, A40169-183, A40169-184, A40169-185, A40169-186, A40169-187, A40169-188, A40169-189, A40169-190, A40169-191, A40734-057, A40734-058, A40734-059, A40734-060, A40734-061, A40734-062, A40734-063, A40734-064, A40734-065, A40734-066, A40734-067, A40734-068, A40734-069, A40734-070, A40734-071, 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Sofamor Danek USA Inc
- Reason for Recall:
- Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309; f) DBM T600612 XPANSE LARGE-L, REF T600612; Demineralized Bone Matrix (DBM) product
Product Codes/Lot Numbers:
a) DBM T600106 XPANSE SMALL-C 6, REF T600106, GTIN 00643169218314, Serial Numbers: A41747-061, A41747-062, A41747-063, A41747-064, A41747-065, A41747-066, A41747-067, A41747-068, A41747-069, A41747-070, A41747-071, A41747-072, A41747-073, A43745-061, A43745-062, A43745-063, A43745-064, A43745-065, A43745-066, A43745-067, A43745-068, A43745-069, A43745-070, A43745-071, A43745-072, A43745-073, A43745-074, A43745-075, A43748-036, A43748-037, A43748-038, A43748-039, A43748-040, A46458-036, A46458-037, A46458-038, A46458-039, A46458-040, A46458-041, A46458-042, A46458-043, A46458-044, A46458-045, A46458-046, A46458-047, A46458-048, A49576-028, A49576-029, A49576-030, A49576-031, A49576-032, A49576-033, A49576-034, A49576-035, A49576-036, A49576-037, A49576-038, A49576-039, A49576-040; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206, GTIN 00643169218352, Serial Numbers: A38618-078, A38618-079, A38618-080, A38618-081, A38618-082, A38618-083, A38618-084, A38618-085, A38618-086, A38618-087, 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A43299-108, A43299-109, A43299-110, A43299-111, A43299-112, A43299-113, A43748-136, A43748-137, A43748-138, A43748-139, A43748-140, A43748-141, A43748-142, A43748-143, A43748-144, A43748-145, A43748-146, A43748-147, A43748-148, A43748-149, A43748-150, A43748-151, A43748-152, A43748-153, A43748-154, A43748-155, A43748-156, A43748-157, A43748-158, A43748-159, A43748-160, A43748-161, A43748-162, A43748-163, A43748-164, A43748-165, A43748-166, A43748-167, A43748-168, A43748-169, A43748-170, A43748-172, A43748-173, A43748-174, A43748-175, A43748-176, A43748-177, A43748-178, A43748-179, A43748-180, A43748-181, A43748-184, A43748-186, A43748-187, A43748-188, A43748-189, A43748-190, A43748-193, A43748-195, A43748-198, A43748-199, A43748-200, A43748-201, A43748-202, A43748-203, A43748-204, A43748-205, A43748-206, A43748-207, A43748-208, A43748-209, A43748-210, A43748-211, A43748-212, A45739-192, A45739-193, A45739-194, A45739-195, A45739-196, A46844-092, A46844-093, A46844-094, A46844-095, A46844-096, A46844-097, A46844-098, A46844-099, A46844-100, A46844-101, A46844-102, A46844-103, A46844-104, A46844-105, A46844-106, A46844-107, A46844-108, A46844-109, A46844-110, A46844-111, A46844-112, A46844-113, A46844-114, A46844-115, A46844-116, A46844-117, A46844-118, A46844-119, A46844-120, A47673-101, A47673-102, A47673-103, A47673-104, A47673-107, A47673-108, A47673-109, A47673-110, A47673-111, A47673-112, A47673-113, A47673-114, A47673-115, A47673-116, A47673-117, A47673-118, A47673-119, A47673-120, A47673-121, A47673-122, A47673-123, A47673-124, A47673-125, A47673-126, A47673-127, A47673-128, A47673-129, A47673-130, A47673-131, A47673-132, A47673-133, A47673-134, A47673-135, A47673-136, A47673-137, A47673-138, A47673-139, A47673-140, A47673-141, A47673-142, A47673-143, A47673-144, A47673-145, A47673-146, A47673-147, A47673-148, A47673-149, A47673-150, A47673-151, A47673-152, A47673-153, A47673-154, A47673-155, A47673-156, A47673-157, A47673-158, A47673-159, A47673-160, A47673-161, A47673-162, A47673-163, A47673-164, A47673-165, A47673-166, A47673-167, A47673-168, A47673-169, A47673-170, A47673-171, A47673-172, A47728-060, A47728-061, A47728-062, A47728-063, A47728-064, A47728-065, A47728-066, A47728-067, A47728-068, A47728-069, A47728-070, A47728-071, A47728-072, A47728-073, A47728-074, A47728-075, A47728-076, A47728-077, A47728-078, A47728-079, A47728-080, A47728-081, A47728-082, A47728-083, A47728-084, A47728-085, A47728-086, A47728-087, A47728-088, A47728-089, A47728-090, A47728-091, A47728-092, A47728-093, A47728-094, A47728-095, A47728-096, A47728-097, A47728-098, A47728-099, A49576-101, A49576-102, A49576-103, A49576-104, A49576-105, A49576-106, A49576-107, A49576-108, A49576-109, A49576-110, A49576-111, A49576-112, A49576-113, A49576-114, A49576-115, A49576-116, A49576-117, A49576-118, A49576-119, A49576-120, A49576-121, A49576-122, A49576-124, A49576-125, A49576-126, A49576-127, A49576-128, A49576-129, A49576-130, A49576-132, A49576-133, A49576-134, A49576-135, A49576-136, A49579-071, A49579-072, A49579-073, A49579-074, A49579-075, A49579-076, A49579-077, A49579-078, A49579-079, A49579-080, A49579-081, A49579-082, A49579-083, A49579-084, A49579-085, A49579-086, A49579-087, A49579-089, A49579-090, A49579-091, A49579-092, A49579-093, A49579-094, A49579-095, A49579-096, A49579-097, A49579-098, A49579-099, A49579-100, A49752-023, A49752-024, A49752-025, A49752-026, A49752-027, A49752-028, A49752-029, A49752-030, A49752-031, A49752-032, A49752-033, A49752-034, A49752-035, A49752-036, A49752-037, A49752-038, A49752-039, A49752-040, A49752-041, A49752-042, A49752-043, A49752-044, A49752-045, A49752-046, A49752-047, A49752-048, A49752-049, A49752-050, A49752-051, A51605-097, A51605-098, A51605-099, A51605-100, A51605-101, A51605-102, A51605-103, A51605-104, A51605-105, A51605-106, A51605-107, A51605-108, A51605-109, A51605-110, A51605-111, A51605-112, A51605-113, A51605-114, A51605-115, A51605-116, A51605-117, A51605-118, A51605-120, A51605-121, A51605-122, A51605-123, A51605-124, A51605-125, A51605-126, A51605-127, A51605-128, A51605-129, A51605-130, A51605-131, A51605-132, A51605-133, A51605-134, A51605-135, A51605-136, A51605-137, A51605-138, A51605-139, A51605-140, A51605-141, A51605-142, A51605-143, A51605-144, A51605-145, A51605-146, A51605-147, A51605-148, A51605-149, A51605-150, A51605-151, A51605-152, A51605-153, A51605-154, A51605-155, A51605-156, A52340-099, A52340-100, A52340-101, A52340-102, A52340-104, A52340-106, A52340-109, A52340-112, A52340-113, A52340-115, A52340-116, A52340-119, A52340-134, A52340-135, A52340-136, A52340-138, A52340-140, A52340-141, A52340-142, A52340-143, A52340-144, A52340-145, A52340-146, A52340-147, A52340-148, A52340-149, A52340-155, A52340-156, A52340-157, A52340-158, A52340-159, A52340-160, A52340-161, A52340-162, A52340-163, A52340-164, A52340-165, A52340-166, A52340-167, A52340-168, A52340-169, A53036-146, A53036-147; d) DBM T600306 XPANSE LARGE-C 6, REF T600306, GTIN 00643169218390, Serial Numbers: A38618-018, A38618-019, A38618-020, A38618-021, A38618-022, A38618-023, A38618-024, A38618-025, A38618-026, A38618-027, A38618-028, A38618-029, A38618-030, A38618-031, A38618-032, A38618-033, A38618-034, A38618-035, A38618-036, A38618-037, A38618-038, A38618-039, A38618-040, A38618-041, A38618-042, A38618-043, A38618-044, A38618-045, A38618-046, A38618-047, A38618-048, A38618-049, A38618-050, A38618-051, A38618-052, A38618-053, A38618-054, A38618-055, A38618-056, A38618-057, A38618-058, A38618-059, A38618-060, A38618-061, A38618-062, A38618-063, A38618-064, A38618-065, A38618-066, A38618-067, A38618-068, A38618-069, A38618-070, A38618-071, A38618-072, A38618-073, A38618-074, A38618-075, A38618-076, A38618-077, A39566-113, A39566-114, A39566-115, A39566-116, A39566-117, A39566-118, A39566-119, A39566-120, A39566-121, A39566-122, A39566-123, A39566-124, A39566-125, A39566-126, A39566-127, A39566-128, A39566-129, A39566-130, A39566-131, A39566-132, A39566-133, A39566-134, A39566-135, A39566-136, A39566-137, A39566-138, A39566-139, A39566-140, A39566-141, A39566-142, A39566-143, A39566-144, A39566-145, A39566-146, A39566-147, A39566-148, A39566-149, A39566-150, A39566-151, A39566-152, A39566-153, A39566-154, A39566-155, A39566-156, A39566-157, A39566-158, A39566-159, A39566-160, A39566-161, A39566-162, A39566-163, A39566-164, A39566-165, A39566-166, A39566-167, A39566-168, A39566-169, A39566-170, A39566-171, A39566-172, A39566-173, A39566-174, A39566-175, A39566-176, A39566-177, A39566-178, A39566-179, A39566-180, A39566-181, A39566-182, A39566-183, A39566-184, A39566-185, A39566-186, A40105-083, A40105-084, A40105-085, A40105-086, A40105-087, A40105-088, A40105-089, A40105-090, A40105-091, A40105-092, A40105-093, A40105-094, A40105-095, A40105-096, A40105-097, A40105-098, A40105-099, A40105-100, A40105-101, A40105-102, A40105-103, A40105-104, A40105-105, A40105-106, A40105-107, A40105-108, A40105-109, A40105-110, A40105-111, A40105-112, A40105-113, A40105-114, A40105-115, A40105-116, A40105-117, A40105-118, A40105-119, A40105-120, A40105-121, A40105-122, A40105-123, A40105-124, A40105-125, A40105-126, A40105-127, A40105-128, A40105-129, A40105-130, A40105-131, A40169-149, A40169-150, A40169-151, A40169-152, A40169-153, A40169-154, A40169-155, A40169-156, A40169-157, A40169-158, A40169-159, A40169-160, A40169-161, A40169-162, A40169-163, A40169-164, A40169-165, A40169-166, A40169-167, A40169-168, A40169-169, A40169-170, A40169-171, A40169-172, A40169-173, A40169-174, A40169-175, A40169-176, A40169-177, A40169-178, A40169-179, A40169-180, A40169-181, A40169-182, A40169-183, A40169-184, A40169-185, A40169-186, A40169-187, A40169-188, A40169-189, A40169-190, A40169-191, A40734-057, A40734-058, A40734-059, A40734-060, A40734-061, A40734-062, A40734-063, A40734-064, A40734-065, A40734-066, A40734-067, A40734-068, A40734-069, A40734-070, A40734-071, A40734-072, A40734-073, A40734-074, A40734-075, A40734-076, A40734-077, A40734-078, A40734-079, A40734-080, A40734-081, A40734-082, A40734-083, A40734-084, A40734-085, A40734-086, A40734-087, A40734-088, A40734-089, A40734-090, A40734-091, A40734-092, A40734-093, A40734-094, A40734-095, A40734-096, A40734-097, A40734-098, A40734-099, A40734-100, A40734-101, A40734-102, A40734-103, A40734-104, A40734-105, A40734-106, A40734-107, A40734-108, A40734-109, A40734-110, A40734-111, A40734-112, A40734-113, A40734-114, A40734-115, A40734-116, A40734-117, A40734-118, A40734-119, A40734-120, A40734-121, A40734-122, A40734-123, A40734-124, A40734-125, A40734-126, A40734-127, A40734-128, A40734-129, A41315-170, A41315-171, A41315-172, A41315-173, A41315-174, A41315-175, A41315-176, A41315-177, A41315-178, A41315-179, A41315-180, A41315-181, A41315-182, A41315-183, A41315-184, A41315-185, A41315-186, A41315-187, A41315-188, A41315-189, A41315-190, A41315-191, A41315-192, A41315-193, A41315-194, A41315-195, A41315-196, A41315-197, A41393-026, A41393-027, A41393-028, A41393-029, A41393-030, A41393-031, A41393-032, A41393-033, A41393-034, A41393-035, A41393-036, A41393-037, A41393-038, A41393-039, A41393-040, A41393-041, A41393-042, A41393-043, A41393-044, A41393-045, A41393-046, A41393-047, A41393-048, A41393-049, A41393-050, A41393-051, A41393-052, A41393-053, A41393-054, A41393-055, A41393-056, A41393-057, A41393-058, A41393-059, A41393-060, A41393-061, A41393-062, A41393-063, A41393-064, A41393-065, A41393-066, A41393-067, A41393-068, A41393-069, A41393-070, A41393-071, A41393-072, A41393-073, A41393-074, A41393-075, A41393-076, A41393-077, A41393-078, A41393-079, A41393-080, A41393-081, A41393-082, A41393-083, A41393-084, A41393-085, A41479-168, A41479-169, A41479-170, A41479-171, A41479-172, A41479-173, A41479-174, A41479-175, A41479-176, A41479-177, A41479-178, A41479-179, A41479-180, A41479-181, A41479-182, A41479-183, A41479-184, A41479-185, A41479-186, A41479-187, A41479-188, A41479-189, A41479-190, A41479-191, A41479-192, A41479-193, A41479-194, A41479-195, A41479-196, A41479-197, A41479-198, A41479-199, A41479-200, A41479-201, A41479-202, A41479-203, A41479-204, A41479-205, A41479-206, A41747-121, A41747-122, A41747-123, A41747-124, A41747-125, A41747-126, A41747-127, A41747-128, A41747-129, A41747-130, A41747-131, A41747-132, A41747-133, A41747-134, A41747-135, A41747-136, A41747-137, A41747-138, A41747-139, A41747-140, A41747-141, A41747-142, A41747-143, A41747-144, A41747-145, A41747-146, A41747-147, A41747-148, A41747-149, A41747-150, A41747-151, A41747-152, A41747-153, A41747-154, A41747-155, A41747-156, A41747-157, A41747-158, A41747-159, A41747-160, A41747-161, A41747-162, A41747-163, A41747-164, A41747-165,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1334-2023
Related Recalls
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medtronic Sofamor Danek USA
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Medtronic Sofamor Danek USA
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.