—#167387

Product

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

FDA product code: GXN — Plate, Cranioplasty, Preformed, Non-Alterable
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K031034
Affected lot / code info: Lot Expiry Date Before: 09/18/2023

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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 Benjamin.Blystone@zimmerbiomet.com .

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2018-08-22
Terminated: 2021-06-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167387. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.