Home / Recalls / Medical Devices
Smith & Nephew Inc recalls GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 714304
Recalled August 28, 2013 · FDA recall Z-1996-2013 · Smith & Nephew
Hazard
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). · FDA Class II
Units
9 units
Sold at
International only: Germany, France, United Arab Emirates, and United Kingdom.
Description
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).
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
Manufacturer(s)
Smith & Nephew Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →