Z-0157-2024Class II

JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis

Name: Z-0157-2024 JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
Creator: Smith & Nephew, Inc.
Published: 2023-09-27
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2023-09-27 / Open, Classified / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis on 2023-09-27. FDA classified it as Class II and gives the reason as "The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0157-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-27
Posted: 2023-10-24
Recalling firm: Smith & Nephew, Inc.
Product: JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Root cause tag: labeling and UDI
FDA root cause: Component change control
Action: Smith & Nephew, Inc. issued an Urgent Medical Device Recall Notice to its consignees on 09/27/2023 via email and overnight mail. The notice explain the issue, potential risk, and requested the following actions: Inspect inventory, locate, and quarantine the affected devices. Sales representatives, district offices, or distributors were directed to notify their customers The firm is seeking return of unused products.
Quantity in commerce: 28 units
Distribution: Worldwide distribution - US Nationwide and the country of Japan.
Product codes and lots: UDI/DI 00885556178010, Batch Number 22BM18348

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0157-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0157-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24
Z-0158-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24

Product code JWH

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)