FDA Device recall Z-0800-2013
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty
- FDA Device
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty by Bacterin International, citing expired product was shipped to two customers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0800-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-18 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bacterin International |
| Distribution | US |
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
Reason
Expired product was shipped to two customers.
Identifiers
| code_info | Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011. A thrid…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0800-2013%22
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