JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM — Class II medical device recall Z-1393-2023
Ongoing recall by Smith & Nephew, Inc., reported 2023-04-26, distributed nationwide. A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UN
| Recall number | Z-1393-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2023-03-27 |
| Classified | 2023-04-14 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| UPC / GTIN / UDI-DI | 00885556677209 |
| Lot numbers | 22CAP0038R |
| Model numbers | 74026178 |
Product
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1393-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.