Recall Z-1099-2022 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew Inc
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
| Date | Apr 19, 2022 |
| Status | Terminated |
| Reason | It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT. |
| Root cause | Nonconforming Material/Component |
| Action | Initial consignees were notified via email and overnight mail on 04/19/2022. The consignees were instructed to inspect their inventory, return affected product, and complete the response form. |
| Quantity | 16 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan. |
| FDA record | Open on fda.gov |