Recall Z-1931-2014— Zimmer, Inc.

Name: FDA recall Z-1931-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-19

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-05-19, terminated 2015-10-29. It names one FDA 510(k) clearance: K043101. Product: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.. Reason: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Terminated: 2015-10-29
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K043101 — NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONSZimmer, Inc.·cleared 2005-03-07

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

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

Reason for recall

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

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