JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
This recall is currently active, issued April 14, 2023. It was issued by Smith & Nephew Inc.
- Company
- Smith & Nephew Inc
- Recall Initiated
- March 27, 2023
- Posted
- April 14, 2023
- Recall Number
- Z-1393-2023
- Quantity
- 12 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
Lot / Code Info
Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
Root Cause
Under Investigation by firm
Action Taken
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.