PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 1, 2023 Initiated: September 27, 2023 #Z-0158-2024

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.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
29 units
Distribution
Worldwide distribution - US Nationwide and the country of Japan.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis. Recalled by Smith & Nephew, Inc.. Units affected: 29 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 1, 2023. Severity: Moderate. Recall number: Z-0158-2024.