Home / Recalls / Zimmer Biomet, Inc. / Z-0395-2019

Z-0395-2019 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

FDA device recall Z-0395-2019 was initiated by Zimmer Biomet, Inc. on Aug 22, 2018 and is designated Class II. Reason for recall: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. The recall status is terminated (terminated Jun 17, 2021). Affected quantity: 23726 units.

Recall Details

Product Type: Devices
Report Date: Nov 14, 2018
Initiation Date: Aug 22, 2018
Termination Date: Jun 17, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23726 units

Product Description

Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 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.

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

Code Information

Lot Expiry Date Before: 09/18/2023

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0395-2019
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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