Recall Z-1393-2023
Smith & Nephew, Inc. · initiated March 27, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Codes / lots: Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
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.
FDA-determined 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.
Details
- Recall number
- Z-1393-2023
- Initiated
- March 27, 2023
- Posted by FDA
- April 14, 2023
- Product code
- HSX – Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Quantity
- 12 units
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN