Smith & Nephew, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0158-2024)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Product Classification:
Class II
Date Initiated: September 27, 2023
Date Posted: November 1, 2023
Recall Number: Z-0158-2024
Event ID: 93156
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.
Status: Ongoing
Product Quantity: 29 units
Code Information:
UDI/DI 00885556176467, Batch Number 22BM17564
Distribution Pattern:
Worldwide distribution - US Nationwide and the country of Japan.
Voluntary or Mandated:
Voluntary: Firm initiated