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.
FDA Recall Z-2281-2016 · Posted None
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLPH
Date Initiated2016-06-03
Date Terminated2018-08-01
Product Quantity1,864 units
Reason for Recall
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Firm Action
Stryker notified its branches/agencies of this recall by e-mail on May 26, 2016. They were asked to quarantine the affected devices. Stryker sent a recall letter and business reply form dated June 3, 2016 to their affected customers via UPS. Stericycle will be handling the returns.
Root Cause
Process design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.