Recall Z-0118-2021— Smith & Nephew, Inc.

Name: FDA recall Z-0118-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-21

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-09-21. It names one FDA 510(k) clearance: K962137. Product: Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.. Reason: The anterior locking detail does not meet its design specifications..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-09-21
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K962137 — GENESIS II CONSTRAINED SYSTEMSmith & Nephew Richards, Inc.·cleared 1996-08-02

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

Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

Reason for recall

The anterior locking detail does not meet its design specifications.

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