Recall Z-1904-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
| Date | Mar 30, 2018 |
| Status | Terminated |
| Reason | The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. |
| Root cause | Packaging process control |
| Action | The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices. |
| Quantity | 16 units |
| Distribution | US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071071 | CROSSLINKED POLYETHYLENE ARTICULAR INSERTS Smith & Nephew, Inc., Sep 19, 2007 |