RecallRadar

FDA Device recall Z-0157-2024

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

On 2023-11-01 the FDA classified a Class II recall of JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262 by Smith And Nephew, citing 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 10….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0157-2024
ClassificationClass II
Statusongoing
Initiated2023-09-27
Published2023-11-01
Last updated2026-09-13 11:56 UTC
CompanySmith And Nephew
DistributionUS

Product

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

Reason

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.

Identifiers

code_infoUDI/DI 00885556178010, Batch Number 22BM18348

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0157-2024%22

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