Recall Z-1393-2023 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Smith & Nephew, Inc.
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
| Date | Apr 14, 2023 (initiated Mar 27, 2023) |
| Status | Open, Classified |
| Reason | A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM. |
| Root cause | Under Investigation by firm |
| Action | Smith & Nephew notified consignees via email and overnight mail on 03/27/2023. Consignees were instructed to immediately review inventory and quarantine any affected units, notify customers if the product was further distributed, complete and return the response form and arrange for the return of affected units. |
| Quantity | 12 units |
| Distribution | US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190085 | Journey II Unicompartmental Knee System Smith & Nephew, Inc., Feb 11, 2019 |