Recall Z-1996-2013— Smith & Nephew Inc

Name: FDA recall Z-1996-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-08

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2013-07-08, terminated 2019-08-19. FDA's recall record names no specific 510(k) clearance for this event. Product: GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic. Reason: The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts)..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Terminated: 2019-08-19
Firm location: Memphis, TN, United States

Product description

GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic

Reason for recall

The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).

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