Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0394-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.

Product Classification:

Class II

Date Initiated: August 22, 2018

Date Posted: November 14, 2018

Recall Number: Z-0394-2019

Event ID: 81072

Reason for Recall:

Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.

Status: Terminated

Product Quantity: 11736 units

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

Voluntary or Mandated:

Voluntary: Firm initiated