OsteoSelect DBM Putty Product Usage: Orthopedic bone filler — Class II medical device recall Z-1138-2013
Terminated recall by Bacterin International, Inc., reported 2013-04-24, distributed nationwide. The firm's retesting procedure was not validated.
| Recall number | Z-1138-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bacterin International, Inc., Belgrade, MT, United States |
| Recall initiated | 2013-02-21 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 165 |
Product
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Reason for recall
The firm's retesting procedure was not validated.
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-1138-2013. 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.