Recalls / —
—#143298
Product
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
- 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
- 14KM16422
Why it was recalled
The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.
Root cause (FDA determination)
Packaging change control
Action the firm took
The firm notified their direct consignee of the issue on 01/18/2016 by email. The notice requested return of the product.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.
Timeline
- Recall initiated
- 2016-01-18
- Terminated
- 2016-05-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #143298. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.