CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report

Biomet Microfixation RapidFlap System RapidFlap SpinDown Clamp recalled

Zimmer Biomet is recalling Biomet Microfixation RapidFlap System RapidFlap SpinDown Clamp, distributed nationwide in the US. The recall was initiated on 22 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Expiry Date Before: 09/18/2023

Quantity recalled11580 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0396-2019
FDA event ID: 81072
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 22 Aug 2018
FDA classified: 6 Nov 2018
Reported: 14 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Aug 2018	Recall initiated by company
6 Nov 2018	Classified by FDA	+76 days
14 Nov 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Is Biomet Microfixation RapidFlap System RapidFlap SpinDown Clamp recalled?

Yes. Zimmer Biomet recalled Biomet Microfixation RapidFlap System RapidFlap SpinDown Clamp on 22 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0396-2019.

Why was it recalled?

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

Which lots are affected?

Lot Expiry Date Before: 09/18/2023

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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