Recalls / —
—#83408
Product
LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K043440
- Affected lot / code info
- Lot Number: 06DM08612.
Why it was recalled
Products were mispackaged.
Root cause (FDA determination)
Process control
Action the firm took
All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E. Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.
Timeline
- Recall initiated
- 2009-01-22
- Posted by FDA
- 2009-08-23
- Terminated
- 2012-02-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #83408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.