Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps o
FDA device recall Z-0416-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Osteotech Inc
- Reason for recall
- Aseptic conditions during the production of these products may have been compromised.
- Action taken
- Osteotech sent a recall letter dated August 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all units of the affected product. Customers were asked to contact Osteotech Customer Service at 732-578-6699 within two business days of receiving the letter to acknowledge receipt of the letter and to arrange for a return and exchange or credit for the product. For questions regarding this recall call 732-542-2800.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- MBP
- Quantity affected
- 18 unts
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-08-08
- Date posted
- 2012-01-11
- Date terminated
- 2011-12-08
- Location
- Eatontown, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRAFTON DBM (K051195) | Osteotech, Inc. | 2005-12-16 |