FDA Device recall Z-2182-2020
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replace…
- FDA Device
- Class II
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class II recall of OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replace… by Osteomed, citing incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2182-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-02 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Osteomed |
| Distribution | US |
Product
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Reason
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Identifiers
| code_info | LOT 1128523, 1129958, 1135746, 1142073, 17071104, 17100404 and 1126669 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2182-2020%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.