Z-0396-2019Class II

Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for...

Name: Z-0396-2019 Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for...
Creator: Zimmer Biomet, Inc.
Published: 2018-08-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-08-22 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of 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... on 2018-08-22. FDA classified it as Class II and gives the reason as "Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0396-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-22
Posted: 2018-11-06
Terminated: 2021-06-17
Recalling firm: Zimmer GmbH
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.
Product code: GXN Plate, Cranioplasty, Preformed, Non-Alterable
Reason for recall: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet conducted recall to the consumer/user level, including any intermediate wholesale or retail consignees. Distributors notified initially via email on 8/22/18. The firm expanded the recall on 10/5/18 to include all lots with lot expiry before 09/18/2023, letters issued via email and FedEx to Distributors/ Risk Managers/Surgeons. Letter identifies issue and requesting removing and return of product. Surgeons will be provided with a letter that identifies the issue and their responsibilities, which include: - Following any specified patient monitoring instructions - Returning Certificate of Acknowledgment to Zimmer Biomet. Hospital risk managers will be provided with a letter identifying the issue. Questions or concerns after reviewing this notice, please call customer service at 907-741-4400 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected] .
Quantity in commerce: 11580 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
Product codes and lots: Lot Expiry Date Before: 09/18/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0396-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0393-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-06
Z-0394-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-06
Z-0395-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-06
Z-0396-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-06
Z-0397-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-06
Z-0398-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-06

Product code GXN

K031034Class IISpin Down RapidflapWalter Lorenz Surgical, Inc. / cleared 2003-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)