Recall Z-1507-2020 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
| Date | Dec 19, 2019 |
| Status | Terminated |
| Reason | LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on January 6, 2020. The letter identified the problem and directed the consignee to quarantine the devices. The notice instructs to complete and return the response form and to make arrangement for the return of affected product. For any questions or concerns please contact: FieldActions@smith-nephew.com. |
| Quantity | 29 units |
| Distribution | USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071071 | CROSSLINKED POLYETHYLENE ARTICULAR INSERTS Smith & Nephew, Inc., Sep 19, 2007 |