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.
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. Quantity: 12 units Lot/code info: Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R
00885556677209
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.