Recall Z-0165-2024 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Medtronic Sofamor Danek USA Inc
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
| Date | Oct 25, 2023 (initiated Sep 26, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Employee error |
| Action | Medtronic issued an URGENT: MEDICAL PRODUCT RECALL notice to its consignees on 09/26/2023 via UPS 2-day delivery. The notice explained the problem, potential risk, and requested the return of the affected devices. |
| Quantity | 430 units |
| Distribution | US, Colombia, S. Korea, New Zealand, India, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051195 | GRAFTON DBM Osteotech, Inc., Dec 16, 2005 |