Device product
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. B100078-908 with expiration date 04/27/2012
Z-0800-2013
Product summary
- Event
- Event 63433
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 packages each containing 2.5cc of putty
- Official record key
device-enforcement:Z-0800-2013
Official wording
Reason: Expired product was shipped to two customers.
Code information: Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011. A thrid graft with ID# B100078-908 expiration date 04/27/2012 was added to the recall 7/12/2012.
Distribution pattern: Nationwide Distribution in TX , GA and CA.
Derived failure modes
-
Unknown
Expired product was shipped to two customers.