Device product
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
Z-0396-2019
Product summary
- Event
- Event 81072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11580 units
- Official record key
device-enforcement:Z-0396-2019
Official wording
Reason: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Code information: Lot Expiry Date Before: 09/18/2023
Distribution pattern: 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
Derived failure modes
-
Unknown
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.