PlainRecalls
FDA Devices Moderate Class II Terminated

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

Reported: November 13, 2013 Initiated: October 7, 2013 #Z-0130-2014

Product Description

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

Reason for Recall

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Details

Recalling Firm
Smith & Nephew Inc
Units Affected
4 units
Distribution
USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic. Recalled by Smith & Nephew Inc. Units affected: 4 units.
Why was this product recalled?
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 13, 2013. Severity: Moderate. Recall number: Z-0130-2014.