—#147771

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.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K151264
Affected lot / code info: Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

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.

Timeline

Recall initiated: 2016-06-03
Terminated: 2018-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147771. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.