OSTEOVATIONEX 3CC IMPACTFORMULA — Class II medical device recall Z-2186-2020
Terminated recall by Osteomed, LLC, reported 2020-06-10, distributed nationwide. Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for t
| Recall number | Z-2186-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Osteomed, LLC, Addison, TX, United States |
| Recall initiated | 2020-04-02 |
| Classified | 2020-05-29 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, IT, KR, MY, PE, SG, TH |
| Quantity | 153 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00813845020030 |
| Lot numbers | 1126984, 1136327, 1156491, 17051907, 17102713 |
Product
OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Reason for recall
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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-2186-2020. 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.