Recall Z-1393-2023— Smith & Nephew, Inc.

Name: FDA recall Z-1393-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-27

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2023-03-27. It names one FDA 510(k) clearance: K190085. Product: JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM. Reason: 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..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-03-27
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K190085 — Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.·cleared 2019-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.