—#75472

Product

Triathlon-Press-Fit Stem These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty.

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: 5565-S-015 TRI PRESS-FIT STEM 15MM X 100MM M3M07B, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM M3M01B, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM M3M01E, 5565-S-017 TRI PRESS-FIT STEM 17MM X 100MM M3M03A, 5566-S-012 TRI PRESS-FIT STEM 12X150MM M3L11F, 5566-S-013 TRI PRESS-FIT STEM 13X150MM M3L12B, and 5566-S-018 TRI PRESS-FIT STEM 18X150MM M3L17D

Why it was recalled

Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

Root cause (FDA determination)

Packaging

Action the firm took

Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.

Recalling firm

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

Distribution

Distribution pattern: Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.

Timeline

Recall initiated: 2008-11-13
Posted by FDA: 2009-01-26
Terminated: 2010-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75472. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.