Z-1393-2023Class II

Journey II Uni Xlpe Tibia Insert Medial Sz 7-8 8Mm

Name: Z-1393-2023 Journey II Uni Xlpe Tibia Insert Medial Sz 7-8 8Mm
Creator: Smith & Nephew, Inc.
Published: 2023-03-27
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2023-03-27 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM on 2023-03-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1393-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-27
Posted: 2023-04-14
Recalling firm: Smith & Nephew, Inc.
Product: Journey II Uni Xlpe Tibia Insert Medial Sz 7-8 8Mm
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by 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.
Quantity in commerce: 12 units
Distribution: US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.
Product codes and lots: Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1393-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1393-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-14

Product code HSX

K190085Class IIJourney II Unicompartmental Knee SystemSmith & Nephew, Inc. / cleared 2019-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)