Recall Z-0415-2012 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Osteotech Inc
Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts
| Date | Jan 11, 2012 (initiated Aug 8, 2011) |
| Status | Terminated |
| Reason | Aseptic conditions during the production of these products may have been compromised. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 15 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051195 | GRAFTON DBM Osteotech, Inc., Dec 16, 2005 |