Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2281-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2016-06-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2281-2016
Date of alert: 2016-06-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Howmedica Osteonics Corp.
Product category: device
Product type: Devices

Reported risk: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2281-2016 — 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.

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