Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020, A44591-021, A44591-022, A44591-023, A44591-024, A44591-025, A44591-026, A44591-027, A44591-028, A44591-029, A44591-030, A44591-031, A44591-032, A44591-033, A44591-034, A44591-035, A44591-036, A44591-037, A44591-039, A44591-041, A44591-042, A44591-043, A44591-044, A44591-045, A44591-046, A44591-047, A44591-048, A44591-049, A44591-050, A44591-051, A44591-052, A44591-053, A44591-054, A44591-055, A44591-056, A44591-057, A44591-058, A44591-059, A44591-060, A44591-061, A44591-062, A44591-064, A44591-065, A44591-066, A44591-067, A44591-068, A44591-069, A44591-070, A44591-071, A44591-072, A44591-073, A44591-074, 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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 DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product

Product Codes/Lot Numbers:

a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020, A44591-021, A44591-022, A44591-023, A44591-024, A44591-025, A44591-026, A44591-027, A44591-028, A44591-029, A44591-030, A44591-031, A44591-032, A44591-033, A44591-034, A44591-035, A44591-036, A44591-037, A44591-039, A44591-041, A44591-042, A44591-043, A44591-044, A44591-045, A44591-046, A44591-047, A44591-048, A44591-049, A44591-050, A44591-051, A44591-052, A44591-053, A44591-054, A44591-055, A44591-056, A44591-057, A44591-058, A44591-059, A44591-060, A44591-061, A44591-062, A44591-064, A44591-065, A44591-066, A44591-067, A44591-068, A44591-069, A44591-070, A44591-071, A44591-072, A44591-073, A44591-074, 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A55325-018, A55325-019, A55325-020, A55325-021, A55325-022, A55325-023, A55325-024, A55325-025, A55325-026, A55325-027, A55325-028, A55325-029, A55325-030, A55325-031, A55325-032, A55325-033, A55325-034, A55383-011, A55383-012, A55383-013, A55383-014, A55383-015, A55383-016, A55383-017, A55383-018, A55383-019, A55383-020, A55383-021, A55383-022, A55383-023, A55383-024, A55383-025, A55383-026, A55383-027, A55383-028, A55383-029, A55383-030, A55383-031, A55383-032, A55383-033, A55383-034, A55383-035, A55383-036, A55383-037, A55383-038, A55383-039, A55383-040, A55383-041, A55383-042, A55383-043, A55383-044, A55383-045, A55383-046, A55383-047, A55383-048, A55652-011, A55652-012, A55652-013, A55652-014, A55652-015, A55652-016, A55652-017, A55652-018, A55652-019, A55652-020, A55652-021, A55652-022, A55652-023, A55652-024, A55652-025, A55652-026, A55652-027, A55652-028, A55652-029, A55652-030, A55652-031, A55652-032, A55652-033, A55652-034, A55652-035, A55652-036, A55652-038, A55652-040, A55652-041, A55652-042, A55652-043, A55652-044, A55652-045, A55652-046, A55652-047, A55652-048, A55652-049, A55652-050, A55652-051, A55652-052, A55741-011, A55741-012, A55741-013, A55741-014, A55741-015, A55741-016, A55741-017, A55741-019, A55741-020, A55741-021, A55741-024, A55741-025, A55741-026, A55741-027, A55741-028, A55741-029, A55741-030, A55741-031, A55741-032, A55741-033, A55741-034, A55741-035, A55741-040, A55741-041, A55741-042, A55741-043, A55741-044, A55741-045, A55799-021, A55799-022, A55799-024, A55799-026, A55799-027, A55799-029, A55799-030, A55958-011, A55958-012, A55958-013, A55958-014, A55958-015, A55958-016, A55958-017, A55958-018, A55958-022, A55958-023, A55958-031, A55958-032; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306, GTIN 00763000254018, Serial Numbers: A46588-011, A46588-012, A46588-013, A46588-014, A46588-015, A46588-016, A46588-017, A46588-018, A46588-019, A46588-020, A46588-021, A46588-022, A46588-023, A46588-024, A46588-025, A46588-026, A46588-027, A46588-028, A46588-029, A46588-030, A46588-031, A46588-032, A46588-033, A46588-034, A46588-035, A46588-036, A46588-037, A46588-038, A46588-039, A46588-040, A46588-041, A46588-042, A46588-043, A46655-011, A46655-012, A46655-013, A46655-014, A46655-015, A46655-016, A46655-017, A46655-018, A46655-019, A46655-020, A46655-022, A46655-023, A46655-024, A46655-025, A46655-026, A46655-027, A46655-028, A46655-029, A46655-030, A46655-031, A46655-032, A46655-033, A46655-034, A46655-035, A46655-036, A46655-037, A46655-038, A46655-040, A46655-041, A46655-042, A46655-043, A46655-044, A46655-045, A46655-046, A46655-047, A46663-011, A46663-012, A46663-013, A46663-014, A46663-015, A46663-016, A46663-017, A46663-018, A46663-019, A46663-020, A46663-021, A46663-022, A46663-023, A46663-024, A46663-025, A46663-028, A46663-029, A46663-031, A46663-032, A46663-033, A46663-034, A46663-035, A46663-036, A46663-037, A46663-038, A46663-040, A46663-041, A46663-042, A46663-043, A46663-044, A46663-045, A46811-011, A46811-012, A46811-013, A46811-014, A46811-015, A46811-016, A46811-017, A46811-018, A46811-019, A46811-020, A46811-021, A46811-022, A46811-023, A46811-024, A46811-025, A46811-028, A46811-029, A46811-030, A46811-031, A46811-032, A46811-033, A46811-034, A46811-035, A46811-036, A46811-038, A46811-039, A46811-040, A46811-041, A46811-042, A46811-043, A46811-044, A46811-045, A46811-046, A46811-047, A46811-048, A46811-049, A46811-050, A46811-051, A46811-052, A46811-053, A46811-054, A46811-055, A46811-056, A46942-011, A46942-012, A46942-013, A46942-014, A46942-015, A46942-016, A46942-017, A46942-018, A46942-019, A46942-020, A46942-021, A46942-022, A46942-023, A46942-024, A46942-025, A46942-026, A46942-027, A46942-028, A46942-029, A46942-030, A46942-031, A46942-032, A46942-033, A46942-034, A47053-011, A47053-012, A47053-013, A47053-014, A47053-015, A47053-016, A47053-017, A47053-018, A47053-019, A47053-020, A47053-021, A47053-022, A47053-023, A47053-024, A47053-025, A47053-026, A47053-027, A47053-028, A47053-029, A47053-030, A47053-031, A47053-032, A47053-033, A47053-034, A47053-035, A47053-036, A47053-037, A47053-038, A47053-039, A47053-040, A47053-041, A47053-042, A47113-011, A47113-012, A47113-013, A47113-014, A47113-015, A47113-016, A47113-017, A47113-018, A47113-019, A47113-020, A47113-021, A47113-023, A47113-024, A47113-025, A47113-026, A47113-027, A47113-028, A47113-029, A47113-030, A47113-031, A47113-032, A47113-033, A47113-034, A47113-035, A47113-036, A47113-037, A47113-038, A47113-039, A47113-040, A47113-041, A47113-042, A47113-043, A47113-044, A47113-045, A47113-046, A47113-048, A47113-049, A47113-050, A47151-011, A47151-012, A47151-013, A47151-014, A47151-016, A47151-017, A47151-018, A47151-019, A47151-020, A47151-021, A47151-022, A47151-023, A47151-024, A47151-025, A47151-026, A47151-027, A47151-028, A47151-029, A47275-026, A47275-027, A47275-028, A47275-029, A47275-030, A47275-031, A47275-032, A47275-033, A47275-034, A47275-035, A47275-036, A47275-037, A47275-038, A47275-039, A47275-040, A47275-041, A47275-042, A47275-043, A47275-044, A47275-045, A47275-047, A47275-048, A47275-049, A47275-050, A47275-051, A47275-052, A47275-053, A47275-054, A47275-055, A47275-056, A47275-057, A47275-058, A47275-059, A47275-060, A47275-062, A47275-063, A47275-064, A47275-065, A47275-066, A47275-067, A47275-068, A47275-069, A47275-070, A47275-071, A47275-072, A47275-073, A47275-074, A47275-075, A47275-076, A47275-077, A47275-078, A47275-079, A47275-080, A47275-081, A47275-082, A47428-013, A47428-014, A47428-015, A47428-016, A47428-019, A47428-020, A47428-021, A47428-022, A47428-023, A47428-024, A47428-025, A47428-026, A47428-027, A47428-028, A47428-029, A47428-030, A47428-031, A47428-032, A47428-033, A47428-035, A47428-036, A47428-037, A47428-038, A47428-039, A47428-040, A47428-041, A47428-042, A47428-043, A47721-011, A47721-012, A47721-013, A47721-014, A47721-015, A47721-016, A47721-017, A47721-018, A47721-019, A47721-020, A47721-021, A47721-022, A47721-023, A47721-024, A47721-025, A47721-026, A47721-027, A47721-028, A47721-029, A47721-030, A47721-031, A47721-032, A47721-033, A47794-011, A47794-012, A47794-013, A47794-014, A47794-015, A47794-017, A47794-018, A47794-019, A47794-020, A47794-021, A47794-022, A47794-023, A47794-024, A47794-025, A47794-026, A47794-027, A47794-028, A47794-029, A47794-030, A47794-031, A47794-032, A47794-033, A47794-034, A47794-035, A47794-036, A47794-037, A47794-038, A47794-039, A47794-040, A47794-041, A47794-042, A47794-043, A47794-044, A47794-045, A47794-046, A47871-011, A47871-012, A47871-013, A47871-014, A47871-016, A47871-017, A47871-018, A47871-019, A47871-020, A47871-021, A47871-022, A47871-023, A47871-024, A47871-025, A47871-026, A47871-027, A47871-028, A47871-029, A47871-030, A47871-031, A47871-032, A47871-033, A47871-034, A47871-035, A47871-036, A47871-037, A47871-038, A47871-039, A47871-040, A47871-041, A47871-042, A47871-043, A47871-044, A47871-045, A47871-046, A47871-047, A47871-048, A47871-049, A47871-050, A47871-051, A47871-052, A47915-011, A47915-012, A47915-013, A47915-014, A47915-015, A47915-016, A47915-017, A47915-018, A47915-019, A47915-020, A47915-021, A47915-022, A47915-023, A47915-025, A47915-026, A47915-028, A47915-029, A47915-030, A47915-031, A47915-032, A47915-033, A47915-034, A47915-035, A47915-036, A47915-037, A47915-039, A47915-040, A47915-041, A47915-042, A47915-043, A47915-045, A47915-046, A47915-047, A47915-048, A47915-049, A47915-050, A47915-051, A47915-052, A47915-053, A47915-054, A47915-055, A47915-057, A47915-058, A47915-059, A47915-060, A47915-061, A47915-062, A47915-063, A47915-064, A47915-065, A47915-066, A47915-067, A47915-068, A47915-069, A47915-070, A47915-071, A47915-072, A47915-073, A47915-074, A47915-075, A47915-076, A47915-077, A48063-011, A48063-012, A48063-013, A48063-014, A48063-015, A48063-016, A48063-017, A48063-018, A48063-019, A48063-020, A48063-021, A48063-022, A48063-023, A48063-024, A48063-025, A48063-026, A48063-027, A48063-028, A48186-011, A48186-012, A48186-013, A48186-014, A48186-015, A48186-016, A48186-017, A48186-018, A48186-019, A48186-020, A48186-021, A48186-022, A48186-023, A48186-024, A48186-025, A48186-026, A48186-027, A48186-028, A48186-029, A48186-030, A48186-031, A48186-032, A48186-033, A48186-034, A48186-035, A48186-036, A48186-039, A48186-040, A48186-042, A48186-043, A48186-044, A48186-045, A48186-046, A48186-047, A48186-049, A48186-050, A48186-051, A48186-052, A48186-053, A48186-054, A48186-055, A48186-056, A48339-026, A48339-027, A48339-028, A48339-029, A48339-030, A48339-031, A48339-032, A48339-033, A48339-034, A48339-035, A48339-036, A48339-037, A48339-038, A48339-039, A48339-040, A48339-041, A48339-042, A48339

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1331-2023

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 →