CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report

Journey Ii Uni Xlpe Tibia Insert Medial Sz recalled by Smith & Nephew

Smith & Nephew is recalling Journey Ii Uni Xlpe Tibia Insert Medial Sz 7-8, distributed nationwide in the US. The recall was initiated on 27 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R

Quantity recalled12 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1393-2023
FDA event ID: 91974
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 27 Mar 2023
FDA classified: 14 Apr 2023
Reported: 26 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

27 Mar 2023	Recall initiated by company
14 Apr 2023	Classified by FDA	+18 days
26 Apr 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Illinois Maryland Michigan Mississippi New York Ohio Texas Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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