FDA Device recall Z-1138-2013
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of OsteoSelect DBM Putty Product Usage: Orthopedic bone filler by Bacterin International, citing the firm's retesting procedure was not validated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1138-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-21 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bacterin International |
| Distribution | US |
Product
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Reason
The firm's retesting procedure was not validated.
Identifiers
| code_info | B100164 and B110115 |
|---|
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-1138-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.