Recall Z-0130-2014— Smith & Nephew Inc

Name: FDA recall Z-0130-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-07

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2013-10-07, terminated 2016-08-23. It names one FDA 510(k) clearance: K951987. Product: GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic. Reason: Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Terminated: 2016-08-23
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K951987 — GENESIS II TOTAL KNEE SYSTEMSmith & Nephew Richards, Inc.·cleared 1995-08-22

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(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.

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