Smith & Nephew, Inc. JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Brand
Smith & Nephew, Inc.
Lot Codes / Batch Numbers
Catalog Number: 74026178, UDI/DI: 00885556677209, Batch Number: 22CAP0038R, Lot Number: 22CAP0038R
Products Sold
Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
Smith & Nephew, Inc. is recalling JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM due to A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM ins. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026