Bacterin International — Class II medical device recall Z-0800-2013
Terminated recall by Bacterin International, Inc., reported 2013-02-20, distributed nationwide. Expired product was shipped to two customers.
| Recall number | Z-0800-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bacterin International, Inc., Belgrade, MT, United States |
| Recall initiated | 2012-04-18 |
| Classified | 2013-02-11 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-05-13 |
| Distributed | Nationwide (US) |
| Expiration dates | 2011-12-25, 2012-04-27 |
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 for recall
Expired product was shipped to two customers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0800-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.