FDA recall Z-1393-2023

Product

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.

Distribution

US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.

Key facts

Status

Ongoing

Initiation date

2023-03-27

Report date

2023-04-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1393-2023