FDA-Device2014-09-03Class II
Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
Zimmer, Inc.
Hazard
Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.
Sold states
Worldwide Distribution -- United States, including Puerto Rico; and, to the countries of Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa & Canada.
Affected count
2,248 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2014Don't want to check this manually?
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