Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
Reported: November 14, 2018 Initiated: August 22, 2018 #Z-0397-2019
Product Description
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
Reason for Recall
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 3246 units
- Distribution
- 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
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.. Recalled by Zimmer Biomet, Inc.. Units affected: 3246 units.
Why was this product recalled? ▼
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0397-2019.
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