Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip — Class II medical device recall Z-2281-2016
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2016-08-03, distributed nationwide. Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam st
| Recall number | Z-2281-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2016-06-03 |
| Classified | 2016-07-25 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2018-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CL, CO, GB, NZ, PL, SE, ZA |
| Quantity | 1,864 units |
| Reason classes | sterility |
| Model numbers | 2199-2022, 2199-2028, 2199-2032 |
Product
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Reason for recall
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
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-2281-2016. 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.