Data Foundry

Medical device recalls 2023

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6 — Class II medical device recall Z-0158-2024

Ongoing recall by Smith & Nephew, Inc., reported 2023-11-01, distributed nationwide. The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD AR

Recall numberZ-0158-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSmith & Nephew, Inc., Memphis, TN, United States
Recall initiated2023-09-27
Classified2023-10-24
Reported by FDA2023-11-01
DistributedNationwide (US)
Countries outside the USJP
Quantity29 units
Reason classeslabeling
UPC / GTIN / UDI-DI00885556176467
Lot numbers22BM17564
Model numbers74029262

Product

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0158-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.