—#87597

Product

Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070095
Affected lot / code info: Catalog number: 5512-F-301; Lot coded: XKYG, XKYH, YBTHR1 and YEUAR1.

Why it was recalled

Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069. All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide Distribution -- United States (DE, NC, OH. MI, TX, CA, MA, NJ, TN, KS, GA, FL, AL, IN, MN, MD, NE, AR, OK, CO, AZ, OR, and MA), Australia, United Kingdom and Canada.

Timeline

Recall initiated: 2009-12-10
Posted by FDA: 2010-02-01
Terminated: 2012-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87597. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.