JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
FDA Recall #Z-1393-2023 — Class II — March 27, 2023
Product Description
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.
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12 units
Distribution
US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
Code Information
Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated