Recall Z-0157-2024— Smith & Nephew, Inc.

Name: FDA recall Z-0157-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-27

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2023-09-27. It names 2 FDA 510(k) clearances: K140555, K111711. Product: JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis. Reason: 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.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-27
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K140555 — JOURNEY II BCS CONSTRAINED INSERTSSmith & Nephew, Inc.·cleared 2014-05-29
K111711 — JOURNEY II BCS KNEE SYSTEMSmith & Nephew, Inc.·cleared 2011-09-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.