PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 26, 2023 Initiated: March 27, 2023 #Z-1393-2023

Product Description

JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 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.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
12 units
Distribution
US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM. Recalled by Smith & Nephew, Inc.. Units affected: 12 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 26, 2023. Severity: Moderate. Recall number: Z-1393-2023.