FDA-Device2018-11-14Class II
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
Zimmer Biomet, Inc.
Hazard
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Sold states
Worldwide distribution: US Nationwide, Canada Argentina Australia Belgium Brazil Chile Colombia Costa Rica Czech Republic Dominican Republic Ecuador Finland France China Ecuador Germany Greece Hong Kong Indonesia Italy Japan Jordan Korea Lebanon Malaysia Netherland Paraguay Peru Singapore South Africa Spain Sweden Switzerland Thailand Trinidad and Tobago Turkey United Arab Emirates United Kingdom Uruguay Vietnam
Affected count
12825 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0393-2019Don't want to check this manually?
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