Recalls / —
—#75471
Product
Triathlon Cemented Stem - Knee 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
- K053514
- Affected lot / code info
- 5560-S-209, TRI CEMENTED STEM 9MMX100MM, Lot N3N31K and 5560-S-209, TRI CEMENTED STEM 9MMX100MM, Lot N3N31W
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 #75471. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.