FDA-Device2025-02-05Class II
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Zimmer, Inc.
Hazard
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Sold states
Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN.
Affected count
155 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2025Don't want to check this manually?
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