FDA Device recall Z-1393-2023
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM by Smith And Nephew, citing 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 Ti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1393-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-27 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
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.
Identifiers
| code_info | Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2024-11-13 · Smith And Nephew
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1393-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.