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Open, Classified

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

FDA Recall Z-1393-2023 · Posted 2023-04-14

Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeHSX
Date Initiated2023-03-27
Product Quantity12 units

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.

Firm Action

Smith & Nephew notified consignees via email and overnight mail on 03/27/2023. Consignees were instructed to immediately review inventory and quarantine any affected units, notify customers if the product was further distributed, complete and return the response form and arrange for the return of affected units.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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