Smith & Nephew, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1393-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 27, 2023

Date Posted: April 26, 2023

Recall Number: Z-1393-2023

Event ID: 91974

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.

Status: Ongoing

Product Quantity: 12 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated