Recall Z-0800-2013 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Bacterin International, Inc.
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep
| Date | Feb 11, 2013 (initiated Apr 18, 2012) |
| Status | Terminated |
| Reason | Expired product was shipped to two customers. |
| Root cause | Incorrect or no expiration date |
| Action | Bacterin International phoned the two customers and they were instructed to return any of the unused product. For questions regarding this recall call 406-388-0480. The 3rd expired product was discovered by Bacterin Sales Rep 7/12/2012 at the consignee. |
| Quantity | 3 packages each containing 2.5cc of putty |
| Distribution | Nationwide Distribution in TX , GA and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091321 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY Bacterin International, Inc., Sep 11, 2009 |