Smith & Nephew, Inc. 2023-04-26 Health serious FDA
Health · FDA · Recall #FDA-Z-1393-2023
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM Recall
Issued April 26, 2023 · Smith & Nephew, Inc.
In April 2023, Smith & Nephew, Inc. recalled the JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Smith & Nephew, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Smith & Nephew, Inc.
- Category
- Health
- Recall date
- April 26, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
- Recall number
- FDA-Z-1393-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Smith & Nephew, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.