Z-0800-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2013
- Initiation Date
- April 18, 2012
- Termination Date
- May 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 packages each containing 2.5cc of putty
Product Description
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
Reason for Recall
Expired product was shipped to two customers.
Distribution Pattern
Nationwide Distribution in TX , GA and CA.
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.