—#65788

Product

Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah, New Jersey

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 Number: 6541-5-723; All lot codes.

Why it was recalled

Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.

Root cause (FDA determination)

Device Design

Action the firm took

Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product replacement.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK.

Timeline

Recall initiated: 2006-09-19
Posted by FDA: 2007-12-11
Terminated: 2008-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65788. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.