Recall Z-0816-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
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.
| Date | Jan 18, 2016 |
| Status | Terminated |
| Reason | 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 | Packaging change control |
| Action | The firm notified their direct consignee of the issue on 01/18/2016 by email. The notice requested return of the product. |
| Quantity | 8 units |
| Distribution | Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043440 | SMITH & NEPHEW, INC. REVISION KNEE SYSTEM Smith & Nephew, Inc., Feb 18, 2005 |