FDA-Device2023-04-26Class II
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Smith & Nephew, Inc.
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.
Sold states
US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
Affected count
12 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1393-2023Don't want to check this manually?
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