Recall Z-0396-2019 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Zimmer Biomet, Inc.
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.
| Date | Aug 22, 2018 |
| Status | Terminated |
| Reason | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 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 Certi |
| Quantity | 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 A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031034 | SPIN DOWN RAPIDFLAP Walter Lorenz Surgical, Inc., May 21, 2003 |