FDAClass IIApril 26, 2023

Journey II UNI Xlpe Tibia Insert Medial SZ 7-8 8mm recall

JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

Why was Journey II UNI Xlpe Tibia Insert Medial SZ 7-8 8mm recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R

Product
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Recalling firm
Smith & Nephew, Inc.
Quantity
12 units
Distribution
US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
Recall date
April 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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