Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for… — Class II medical device recall Z-0811-2020
Terminated recall by Howmedica Osteonics Corp., reported 2020-01-22, distributed in CA, FL, GA, IA, MA, MI, NC, OH…. May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of
| Recall number | Z-0811-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2019-11-07 |
| Classified | 2020-01-15 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2020-08-31 |
| Distributed | CA, FL, GA, IA, MA, MI, NC, OH, WI |
| Countries outside the US | CA, JP |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 04546540035806 |
| Lot numbers | 53778501 |
| Model numbers | 2041C-3254 |
Product
Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
Reason for recall
May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
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-0811-2020. 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.