OMNI K2 Hip Stem — Class II medical device recall Z-0237-2022
Terminated recall by OmniLife Science, reported 2021-11-24, distributed in CO, VA. The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibi
| Recall number | Z-0237-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OmniLife Science, Raynham, MA, United States |
| Recall initiated | 2021-10-01 |
| Classified | 2021-11-16 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2022-07-20 |
| Distributed | CO, VA |
| Quantity | 7 |
| UPC / GTIN / UDI-DI | 00841690102496 |
| Lot numbers | 38933 |
Product
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Reason for recall
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
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-0237-2022. 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.