Z-1393-2023 Class II Ongoing
FDA device recall Z-1393-2023 was initiated by Smith & Nephew, Inc. on March 27, 2023 and is designated Class II. 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 Siz… The recall status is ongoing. Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- March 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
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.
Distribution Pattern
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