FDA-Device2016-08-10Class II
V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Zimmer Gmbh
Hazard
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
Sold states
Domestic: CO, IL Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan, Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong, Philippines, Iran, Brazil, Turkey, United Arab Emirates (UAE), Uruguay
Affected count
169
Manufactured in
Sulzer Allee 8, Winterthur, Switzerland
Products
V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2324-2016Don't want to check this manually?
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