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Open, Classified

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

FDA Recall Z-0158-2024 · Posted 2023-10-24

Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2023-09-27
Product Quantity29 units

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.

Firm 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.

Root Cause

Component change control

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111711JOURNEY II BCS KNEE SYSTEMSmith & Nephew, Inc. · 2011-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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