JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
FDA Recall #Z-0158-2024 — Class II — September 27, 2023
Product Description
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.
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
29 units
Distribution
Worldwide distribution - US Nationwide and the country of Japan.
Code Information
UDI/DI 00885556176467, Batch Number 22BM17564
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated