FDA-Device2017-06-21Class II

Segmental fluted stem, 18x250mm bwd, Sterile,

Zimmer Biomet, Inc.
Hazard

Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

Sold states
Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
Affected count
9867
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Segmental fluted stem, 18x250mm bwd, Sterile,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2574-2017

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