Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
FDA device recall Z-0166-2024 · posted 2023-10-25 · Open, Classified
Recall details
- Recalling firm
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- MBP
- Quantity affected
- 583 units
- Distribution
- US, Colombia, S. Korea, New Zealand, India, Taiwan
- Date initiated
- 2023-09-26
- Date posted
- 2023-10-25
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRAFTON DBM (K051195) | Osteotech, Inc. | 2005-12-16 |
| GRAFTON PLUS DBM PASTE (K043048) | Osteotech, Inc. | 2005-11-23 |