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Zimmer Biomet, Inc. recalls Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of t
Recalled November 14, 2018 · FDA recall Z-0393-2019 · Zimmer Biomet
Hazard
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. · FDA Class II
Units
12825 units
Sold at
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
Description
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Product
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →