Smith & Nephew, Inc. Recall 91974
Description: JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Smith & Nephew, Inc. Recall 91974 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1393-2023 |
| Event ID | 91974 |
| Event Description | JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA. |
| Quantity | 12 units |
| Recall 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. |
| Device Classification | 20230426 |
| Device Code Info | Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R |
| Center Classification Date | 20230414 |
| Recall Initiation Date | 20230327 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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