🔍 RecallPedia

Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix

Class I - Dangerous
🏥 Medical Devices Recalled: September 26, 2023 Medtronic Sofamor Danek USA Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    a) T44125INT: GTIN 00643169965058, Serial Numbers: A52559-042, A52559-024, A52559-038, A52559-039, A52559-040, A52559-041, A52559-044, A52559-045, A52559-021, A52559-022, A52559-023, A52559-025, A52559-026, A52559-027, A52559-028, A52559-029, A52559-030, A52559-031, A52559-032, A52559-033, A52559-034, A52559-035, A52559-036, A52559-037, A52559-043; b) T44135: GTIN 00643169122918, Serial Numbers: A59102-034, A59102-035, A58789-025, A58789-026, A58789-027, A59080-036, A59080-037, A58789-030, A58789-031, A58789-032, A58789-033, A58789-034, A58789-035, A58789-036, A58789-037, A58789-038, A58789-039, A59102-042, A59102-043, A59102-044, A59102-045, A59102-046, A59102-047, A59102-048, A59102-049, A59102-050, A59102-051, A59103-030, A59103-031, A59103-032, A59103-033, A59103-034, A59103-035, A59103-036, A59103-037, A59103-038, A59103-039, A59102-055, A59102-056, A58789-061, A58789-062, A59080-022, A59080-026, A59080-027, A59080-028, A59080-029, A59080-030, A59102-038, A59102-039, A59102-040, A59102-041, A59102-059, A59102-060, A59102-061, A59102-062, A58789-047, A59103-042, A59103-043, A59103-044, A59103-045, A59103-046, A58789-028, A58789-029, A59080-020, A59080-021, A59080-023, A59102-031, A59102-032, A59102-033, A59080-024, A59080-025, A59102-029, A59103-040, A59080-031, A59080-016, A59080-017, A58789-042, A58789-043, A58789-044, A58789-045, A58789-046, A58789-048, A58789-049, A58789-021, A58789-022, A58789-023, A59080-019, A59102-057, A59102-058, A59103-041, A58789-050, A58789-054, A58789-055, A58789-056, A58789-057, A58789-058, A58789-059, A58789-060, A59103-016, A59103-017, A59103-018, A59103-029, A59080-018, A59102-028, A59102-030, A59102-052, A59102-053, A59102-054; c) T44145: GTIN 00643169122925, Serial Numbers: A56911-076, A56911-070, A56911-071, A56911-023, A56911-067, A47028-065, A56911-082, A59197-041, A59197-059, A56911-074, A56911-075, A47028-053, A57248-034, A56911-018, A59197-057, A59197-036, A59197-037, A59197-020, A59197-021, A59197-022, A59197-023, A59197-024, A56911-028, A56911-029, A56911-030, A56911-031, A56911-033, A57248-039, A56911-034, A56911-035, A56911-080, A59197-034, A56911-077, A56911-078, A56911-079, A59197-047, A59197-044, A56911-068, A56911-044, A56911-045, A56911-046, A56911-081, A57248-020, A57248-032, A57248-036, A59197-062, A56911-032, A59197-055, A59197-051, A59197-052, A57248-025, A57248-026, A57248-027, A57248-028, A57248-029, A56911-041, A59197-048, A56911-020, A56911-024, A56911-025, A56911-047, A56911-048, A56911-049, A56911-050, A56911-051, A56911-052, A56911-053, A56911-054, A56911-055, A56911-056, A56911-057, A56911-058, A56911-042, A56911-043, A56911-072, A56911-073, A57248-013, A57248-014, A47028-036, A47028-037, A47028-038, A56911-059, A47028-039, A56911-027, A47028-040, A59197-011, A59197-012, A59197-013, A47028-059, A57248-033, A59197-018, A59197-019, A47028-066, A47028-067, A59197-049, A59197-050, A47028-041, A47028-042, A59197-040, A47028-043, A47028-044, A57248-011, A57248-012, A59197-025, A59197-026, A59197-027, A59197-028, A59197-029, A59197-030, A59197-031, A59197-032, A59197-033, A56911-019, A56911-021, A56911-022, A56911-060, A56911-061, A56911-062, A56911-063, A56911-064, A56911-065, A56911-066, A57248-030, A57248-031, A57248-035, A59197-038, A59197-039, A59197-060, A59197-061, A57248-038, A59197-054, A47028-045, A47028-046, A47028-047, A47028-048, A59197-014, A59197-015, A59197-016, A59197-017, A56911-069, A59197-045, A57248-015, A57248-016, A57248-017, A57248-018, A56911-036, A56911-037, A56911-038, A56911-039, A56911-040, A47028-049, A47028-050, A47028-051, A47028-052, A57248-037, A59197-064, A59197-065, A47028-054, A59197-042, A59197-043, A59197-053, A56911-026, A59197-056, A57248-019, A47028-055, A47028-056, A59197-046, A59197-063, A59197-058, A47028-057, A47028-058, A59197-035; d) T44150: GTIN 00643169122932, Serial Numbers: A48245-164, A48245-168, A57914-011, A57914-012, A57914-023, A57914-024, A57914-025, A59191-061, A59191-058, A58758-035, A58758-036, A58758-037, A58758-059, A59191-038, A59191-039, A58758-034, A58758-038, A59191-040, A48245-121, A48245-122, A48245-123, A48245-124, A48245-147, A48245-148, A48245-149, A48245-160, A48245-170, A58758-060, A58758-061, A58758-062, A59191-062, A59191-063, A59191-064, A58758-039, A57914-013, A57914-014, A57914-015, A57914-016, A57914-017, A58758-040, A58758-041, A58758-042, A59191-041, A58758-043, A58758-044, A48245-165, A48245-166, A48245-167, A48245-169, A58758-045, A58758-046, A58758-050, A58758-051, A58758-047, A58758-048, A58758-049, A59191-042, A59191-043, A59191-044, A58758-031, A58758-032, A58758-033, A59191-045, A59191-046, A59191-047, A59191-048, A59191-049, A48245-135, A48245-136, A48245-137, A48245-138, A48245-139, A48245-140, A48245-141, A48245-142, A48245-143, A48245-144, A48245-145, A48245-146, A48245-150, A48245-151, A48245-152, A48245-153, A48245-154, A48245-155, A48245-156, A48245-157, A57914-018, A57914-019, A57914-020, A57914-021, A57914-022, A48245-161, A48245-125, A48245-126, A48245-127, A48245-128, A48245-129, A48245-130, A48245-131, A48245-132, A48245-133, A48245-134, A48245-158, A48245-159, A48245-162, A59191-050, A59191-051, A48245-163, A58758-052, A59191-052, A59191-053, A58758-063, A59191-060, A58758-053, A58758-054, A58758-055, A59191-054, A59191-055, A59191-059, A58758-056, A58758-057, A58758-058, A59191-056, A59191-057
  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:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix

Product Codes/Lot Numbers:

a) T44125INT: GTIN 00643169965058, Serial Numbers: A52559-042, A52559-024, A52559-038, A52559-039, A52559-040, A52559-041, A52559-044, A52559-045, A52559-021, A52559-022, A52559-023, A52559-025, A52559-026, A52559-027, A52559-028, A52559-029, A52559-030, A52559-031, A52559-032, A52559-033, A52559-034, A52559-035, A52559-036, A52559-037, A52559-043; b) T44135: GTIN 00643169122918, Serial Numbers: A59102-034, A59102-035, A58789-025, A58789-026, A58789-027, A59080-036, A59080-037, A58789-030, A58789-031, A58789-032, A58789-033, A58789-034, A58789-035, A58789-036, A58789-037, A58789-038, A58789-039, A59102-042, A59102-043, A59102-044, A59102-045, A59102-046, A59102-047, A59102-048, A59102-049, A59102-050, A59102-051, A59103-030, A59103-031, A59103-032, A59103-033, A59103-034, A59103-035, A59103-036, A59103-037, A59103-038, A59103-039, A59102-055, A59102-056, A58789-061, A58789-062, A59080-022, A59080-026, A59080-027, A59080-028, A59080-029, A59080-030, A59102-038, A59102-039, A59102-040, A59102-041, A59102-059, A59102-060, A59102-061, A59102-062, A58789-047, A59103-042, A59103-043, A59103-044, A59103-045, A59103-046, A58789-028, A58789-029, A59080-020, A59080-021, A59080-023, A59102-031, A59102-032, A59102-033, A59080-024, A59080-025, A59102-029, A59103-040, A59080-031, A59080-016, A59080-017, A58789-042, A58789-043, A58789-044, A58789-045, A58789-046, A58789-048, A58789-049, A58789-021, A58789-022, A58789-023, A59080-019, A59102-057, A59102-058, A59103-041, A58789-050, A58789-054, A58789-055, A58789-056, A58789-057, A58789-058, A58789-059, A58789-060, A59103-016, A59103-017, A59103-018, A59103-029, A59080-018, A59102-028, A59102-030, A59102-052, A59102-053, A59102-054; c) T44145: GTIN 00643169122925, Serial Numbers: A56911-076, A56911-070, A56911-071, A56911-023, A56911-067, A47028-065, A56911-082, A59197-041, A59197-059, A56911-074, A56911-075, A47028-053, A57248-034, A56911-018, A59197-057, A59197-036, A59197-037, A59197-020, A59197-021, A59197-022, A59197-023, A59197-024, A56911-028, A56911-029, A56911-030, A56911-031, A56911-033, A57248-039, A56911-034, A56911-035, A56911-080, A59197-034, A56911-077, A56911-078, A56911-079, A59197-047, A59197-044, A56911-068, A56911-044, A56911-045, A56911-046, A56911-081, A57248-020, A57248-032, A57248-036, A59197-062, A56911-032, A59197-055, A59197-051, A59197-052, A57248-025, A57248-026, A57248-027, A57248-028, A57248-029, A56911-041, A59197-048, A56911-020, A56911-024, A56911-025, A56911-047, A56911-048, A56911-049, A56911-050, A56911-051, A56911-052, A56911-053, A56911-054, A56911-055, A56911-056, A56911-057, A56911-058, A56911-042, A56911-043, A56911-072, A56911-073, A57248-013, A57248-014, A47028-036, A47028-037, A47028-038, A56911-059, A47028-039, A56911-027, A47028-040, A59197-011, A59197-012, A59197-013, A47028-059, A57248-033, A59197-018, A59197-019, A47028-066, A47028-067, A59197-049, A59197-050, A47028-041, A47028-042, A59197-040, A47028-043, A47028-044, A57248-011, A57248-012, A59197-025, A59197-026, A59197-027, A59197-028, A59197-029, A59197-030, A59197-031, A59197-032, A59197-033, A56911-019, A56911-021, A56911-022, A56911-060, A56911-061, A56911-062, A56911-063, A56911-064, A56911-065, A56911-066, A57248-030, A57248-031, A57248-035, A59197-038, A59197-039, A59197-060, A59197-061, A57248-038, A59197-054, A47028-045, A47028-046, A47028-047, A47028-048, A59197-014, A59197-015, A59197-016, A59197-017, A56911-069, A59197-045, A57248-015, A57248-016, A57248-017, A57248-018, A56911-036, A56911-037, A56911-038, A56911-039, A56911-040, A47028-049, A47028-050, A47028-051, A47028-052, A57248-037, A59197-064, A59197-065, A47028-054, A59197-042, A59197-043, A59197-053, A56911-026, A59197-056, A57248-019, A47028-055, A47028-056, A59197-046, A59197-063, A59197-058, A47028-057, A47028-058, A59197-035; d) T44150: GTIN 00643169122932, Serial Numbers: A48245-164, A48245-168, A57914-011, A57914-012, A57914-023, A57914-024, A57914-025, A59191-061, A59191-058, A58758-035, A58758-036, A58758-037, A58758-059, A59191-038, A59191-039, A58758-034, A58758-038, A59191-040, A48245-121, A48245-122, A48245-123, A48245-124, A48245-147, A48245-148, A48245-149, A48245-160, A48245-170, A58758-060, A58758-061, A58758-062, A59191-062, A59191-063, A59191-064, A58758-039, A57914-013, A57914-014, A57914-015, A57914-016, A57914-017, A58758-040, A58758-041, A58758-042, A59191-041, A58758-043, A58758-044, A48245-165, A48245-166, A48245-167, A48245-169, A58758-045, A58758-046, A58758-050, A58758-051, A58758-047, A58758-048, A58758-049, A59191-042, A59191-043, A59191-044, A58758-031, A58758-032, A58758-033, A59191-045, A59191-046, A59191-047, A59191-048, A59191-049, A48245-135, A48245-136, A48245-137, A48245-138, A48245-139, A48245-140, A48245-141, A48245-142, A48245-143, A48245-144, A48245-145, A48245-146, A48245-150, A48245-151, A48245-152, A48245-153, A48245-154, A48245-155, A48245-156, A48245-157, A57914-018, A57914-019, A57914-020, A57914-021, A57914-022, A48245-161, A48245-125, A48245-126, A48245-127, A48245-128, A48245-129, A48245-130, A48245-131, A48245-132, A48245-133, A48245-134, A48245-158, A48245-159, A48245-162, A59191-050, A59191-051, A48245-163, A58758-052, A59191-052, A59191-053, A58758-063, A59191-060, A58758-053, A58758-054, A58758-055, A59191-054, A59191-055, A59191-059, A58758-056, A58758-057, A58758-058, A59191-056, A59191-057

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0165-2024

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 →

Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

Medtronic Sofamor Danek USA

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 →