—#82480

Product

Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog Numbers: 6543-8-014, 6543-8-015.

Why it was recalled

The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.

Root cause (FDA determination)

Process change control

Action the firm took

Stryker Orthopaedics issued an "Urgent Product Correction" notice dated May 15, 2009 via Federal Express addressed to Branch/Agency Manager/Quality Contact informing them of the affected device. The letter outlined instructions for correction and requested consignees to complete and return a Product Correction Acknowledgment Form by fax to 1-201-831-6069. Questions can be directed to Colleen O'Meara, Manager, Divisional Regulatory Reporting at 201-831-5970.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US and Canada.

Timeline

Recall initiated: 2009-05-15
Posted by FDA: 2009-07-15
Terminated: 2010-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.