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FDA (Device enforcement)Recalled 2023-03-27class ii

Smith & Nephew, Inc.: JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

Hazard

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.

Details from the source

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

UPC codes

00885556677209

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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