FDA-Device2014-07-09Class II
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Zimmer, Inc.
Hazard
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
Affected count
41,180 total
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1935-2014Don't want to check this manually?
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