FDA-Device2014-07-16Class II
Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Zimmer, Inc.
Hazard
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
Affected count
852 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2034-2014Don't want to check this manually?
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