OsteoVation — Class II medical device recall Z-0866-2021
Terminated recall by Skeletal Kinetics, Llc, reported 2021-01-27, distributed nationwide. A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc
| Recall number | Z-0866-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Skeletal Kinetics, Llc, Addison, TX, United States |
| Recall initiated | 2019-06-06 |
| Classified | 2021-01-15 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2024-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Lot numbers | 1129957 |
| Model numbers | 390-2005 |
Product
OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Reason for recall
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
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-0866-2021. 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.