Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT; h) DBM T43102 1CC GRAFTON PUTTY, REF T43102; i) DBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT; j) DBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN; k) DBM T43103 2.5CC GRAFTON PUTTY, REF T43103; l) DBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT; m) DBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN; n) DBM T43105 5CC GRAFTON PUTTY, REF T43105; o) DBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT; p) DBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN; q) DBM T43110 10CC GRAFTON PUTTY, REF T43110; r) DBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT; Demineralized Bone Matrix (DBM) product

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers: A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers: A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers: A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers: A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers: A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A54172, A54245, A54678, A54994; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101, GTIN 00643169123106, Serial Numbers: A38151-037, A38151-038, A38151-039, A38151-040, A38151-041, A38151-042, A38151-043, A38151-045, A38151-049, A38151-050, A38151-051, A38151-052, A38151-053, A38151-054, A38151-055, A38151-056, A38151-057, A38151-058, A38151-059, A38151-060, A38151-061, A38151-062, A38151-063, A38151-064, A38151-065, A38151-066, A38151-067, A38151-068, A38151-069, A38151-070, A38151-071, A38151-072, 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A40115-076, A40115-077, A40115-078, A40115-079, A40115-080, A40115-081, A40115-082, A40115-083, A40115-084, A40115-085, A40115-086, A40115-087, A40115-088, A40115-089, A40115-090, A40115-091, A40115-092, A40115-093, A40115-094, A40115-095, A40115-096, A40601-011, A40601-012, A40601-013, A40601-014, A40601-015, A40601-016, A40601-017, A40601-018, A40601-019, A40601-020, A40601-021, A40601-022, A40601-023, A40601-024, A40601-025, A40601-026, A41784-098, A41784-099, A41784-100, A41784-101, A41784-102, A41784-103, A41784-104, A41784-105, A41784-106, A41784-107, A41784-108, A41784-109, A41784-110, A41784-111, A41784-112, A41784-113, A41784-114, A41784-115, A41784-116, A41784-117, A41784-118, A41784-119, A41784-122, A41784-123, A41784-124, A41784-125, A41784-126, A41784-127, A41784-128, A41784-129, A41784-130, A41784-131, A41784-132, A41784-133, A41784-134, A41784-135, A41784-136, A41784-137, A41784-138, A41784-139, A41784-140, A41784-141, A41784-142, A41784-143, A41784-144, A41784-145, 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A41784-230, A41784-231, A41784-232, A41784-233, A41784-234, A41784-235, A41784-236, A41784-237, A41784-238, A41784-239, A41784-240, A41784-241, A41784-242, A41784-243, A41784-244, A41784-245, A41784-246, A42116-102, A42116-103, A42116-104, A42116-105, A42116-106, A42116-107, A42116-108, A42116-109, A42116-110, A42116-111, A42116-112, A42116-113, A42116-114, A42116-115, A42116-116, A42116-117, A42116-118, A42116-119, A42116-120, A42116-121, A42116-122, A42116-123, A42116-124, A42116-125, A42116-126, A42116-127, A42116-128, A42116-129, A42116-130, A42116-131, A42116-132, A42116-133, A42116-134, A42116-135, A42116-136, A42116-137, A42116-138, A42116-139, A42116-140, A42116-141, A42116-142, A42116-143, A42116-144, A42116-145, A42116-146, A42116-147, A42116-148, A42116-149, A42116-150, A42116-151, A42116-152, A42116-153, A42116-155, A42116-156, A42116-157, A42116-158, A42116-159, A42116-160, A42116-161, A42116-162, A42116-163, A42116-164, A42116-165, A42116-166, A42409-021, A42409-022, 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A42409-107, A42409-108, A42409-109, A42409-110, A42409-111, A42409-112, A42409-113, A42518-011, A42518-012, A42518-013, A42518-014, A42518-015, A42518-016, A42518-017, A42518-018, A42518-019, A42518-020, A42518-021, A42518-022, A42518-023, A42518-024, A42518-025, A42518-026, A42518-027, A42518-028, A42518-029, A42518-030, A42518-031, A42518-032, A42518-033, A42518-034, A42518-035, A42518-036, A42518-037, A42518-038, A42518-039, A42518-040, A42518-041, A42518-042, A42518-043, A42518-044, A42518-045, A42518-046, A42518-047, A42518-048, A42518-049, A42518-050, A42956-011, A42956-012, A42956-013, A42956-014, A42956-015, A42956-016, A42956-017, A42956-018, A42956-019, A42956-020, A42956-021, A42956-022, A42956-023, A42956-024, A42956-025, A42956-026, A42956-027, A42956-028, A42956-029, A42956-030, A42956-031, A42956-032, A43483-011, A43483-012, A43483-013, A43483-014, A43483-015, A43483-016, A43483-017, A43483-018, A43483-019, A43483-020, A43483-021, A43483-022, A43483-023, A43483-024, A43483-025, A43483-026, A43483-027, A43483-028, A43483-029, A43483-030, A43483-031, A43483-032, A43483-033, A43483-034, A43483-035, A43483-036, A43483-037, A43483-038, A43483-039, A43483-040, A43483-041, A43483-042, A43483-043, A43483-044, A43483-045, A43483-046, A43483-047, A43483-048, A43483-049, A43483-050, A43840-011, A43840-012, A43840-013, A43840-014, A43840-015, A43840-016, A43840-017, A43840-018, A43840-019, A43840-020, A43840-021, A43840-022, A43840-023, A43840-024, A43840-025, A43840-026, A43840-027, A43840-028, A43840-029, A43840-030, A43840-031, A43840-032, A43840-033, A43840-034, A43840-035, A43840-036, A43903-090, A43903-091, A43903-092, A43903-093, A43903-094, A43903-095, A43903-096, A43903-097, A43903-098, A43903-099, A43903-100, A43903-101, A43903-102, A43903-103, A43903-104, A43903-105, A43903-106, A43903-107, A43903-108, A43903-109, A43903-110, A43903-111, A43903-112, A43903-113, A43903-114, A43903-115, A43903-116, A43903-117, A43903-118, A43903-119, A43903-120, A43903-121, A43903-122, A43903-123, A43903-124, A43903-125, A43903-126, A43903-127, A43903-128, A43903-129, A43903-130, A43903-131, A43903-132, A43903-133, A43903-134, A43903-135, A43903-136, A43903-137, A43903-138, A43903-139, A43903-140, A43903-141, A43903-142, A43903-143, A43903-144, A43903-145, A43903-146, A43903-147, A43903-148, A43903-149, A43903-150, A43903-151, A43903-152, A43903-153, A43903-154, A43903-155, A43903-156, A43903-157, A43903-158, A43903-159, A43903-160, A43903-161, A43903-162, A43903-163, A43903-164, A43903-165, A43903-166, A43903-167, A43903-168, A43903-169, A43903-170, A43903-171, A43903-172, A43903-173, A43903-174, A43903-175, A43903-176, A43903-177, A43903-178, A43903-179, A43903-180, A43903-181, A43903-182, A43903-183, A43903-184, A43903-185, A43903-186, A43903-187, A43903-188, A43903-189, A43903-190, A43937-056, A43937-057, A43937-058, A43937-059, A43937-060, A43937-061, A43937-062, A43937-063, A43937-064, A43937-065, A43937-066, A43937-067, A43937-068, 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  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT; h) DBM T43102 1CC GRAFTON PUTTY, REF T43102; i) DBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT; j) DBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN; k) DBM T43103 2.5CC GRAFTON PUTTY, REF T43103; l) DBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT; m) DBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN; n) DBM T43105 5CC GRAFTON PUTTY, REF T43105; o) DBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT; p) DBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN; q) DBM T43110 10CC GRAFTON PUTTY, REF T43110; r) DBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT; Demineralized Bone Matrix (DBM) product

Product Codes/Lot Numbers:

a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers: A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers: A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers: A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers: A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers: A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A54172, A54245, A54678, A54994; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101, GTIN 00643169123106, Serial Numbers: A38151-037, A38151-038, A38151-039, A38151-040, A38151-041, A38151-042, A38151-043, A38151-045, A38151-049, A38151-050, A38151-051, A38151-052, A38151-053, A38151-054, A38151-055, A38151-056, A38151-057, A38151-058, A38151-059, A38151-060, A38151-061, A38151-062, A38151-063, A38151-064, A38151-065, A38151-066, A38151-067, A38151-068, A38151-069, A38151-070, A38151-071, A38151-072, 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Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1323-2023

Related Recalls

Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217.

Medtronic Sofamor Danek USA

Class I - Dangerous

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.

Sep 16, 2025 Implants & Prosthetics Nationwide View Details →
Class I - Dangerous

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.

Sep 26, 2023 Other Medical Devices View Details →