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Recall Observatory FDA recall evidence

Device 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.

Z-2281-2016

June 03, 2016

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 74500
Status
Terminated
Classification
Class II
Quantity
1,864 units
Official record key
device-enforcement:Z-2281-2016

Official wording

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

Code information: Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012

Distribution pattern: Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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