Recall Z-2281-2016— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2016-06-03, terminated 2018-08-01. It names one FDA 510(k) clearance: K151264. 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: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-03
- Terminated
- 2018-08-01
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.