FDA-Device2017-06-21Class II

Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

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
Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2559-2017

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