Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101, GTIN 00643169656017, Serial Numbers: A40005-036, A40005-037, A40005-038, A40005-039, A40005-040, A40005-041, A40005-042, A40005-043, A40005-045, A40005-046, A40005-047, A40005-048, A40005-049, A40005-051, A40005-053, A40005-054, A40005-055, A40005-056, A40005-057, A40005-058, A40005-059, A40005-060, A40005-061, A40005-062, A40005-063, A40005-064, A40005-065, A40005-066, A40005-067, A40005-068, A40005-069, A40005-070, A40005-071, A40005-072, A40005-073, A40005-074, A40005-075, A40005-076, A40005-077, A40005-078, A40005-079, A40005-080, A40005-081, A40005-082, A40005-083, A40005-084, A40005-085, A40005-086, A40005-087, A40005-088, A40005-089, A40005-090, A40005-091, A40005-092, A40005-093, A40005-094, A40005-095, A40005-096, A40005-097, A40005-098, A40005-099, A40005-100, A40005-101, A40005-102, A40304-210, A40304-211, A40304-212, A40304-213, A40304-214, A40304-215, A40304-216, A40304-217, A40304-218, A40304-219, A40304-220, A40304-221, 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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: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product

Product Codes/Lot Numbers:

a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101, GTIN 00643169656017, Serial Numbers: A40005-036, A40005-037, A40005-038, A40005-039, A40005-040, A40005-041, A40005-042, A40005-043, A40005-045, A40005-046, A40005-047, A40005-048, A40005-049, A40005-051, A40005-053, A40005-054, A40005-055, A40005-056, A40005-057, A40005-058, A40005-059, A40005-060, A40005-061, A40005-062, A40005-063, A40005-064, A40005-065, A40005-066, A40005-067, A40005-068, A40005-069, A40005-070, A40005-071, A40005-072, A40005-073, A40005-074, A40005-075, A40005-076, A40005-077, A40005-078, A40005-079, A40005-080, A40005-081, A40005-082, A40005-083, A40005-084, A40005-085, A40005-086, A40005-087, A40005-088, A40005-089, A40005-090, A40005-091, A40005-092, A40005-093, A40005-094, A40005-095, A40005-096, A40005-097, A40005-098, A40005-099, A40005-100, A40005-101, A40005-102, A40304-210, A40304-211, A40304-212, A40304-213, A40304-214, A40304-215, A40304-216, A40304-217, A40304-218, A40304-219, A40304-220, A40304-221, 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Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1330-2023

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 →