Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Microfixation RapidFlap

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Biomet Microfixation RapidFlap see related information
Date Initiated by Firm August 22, 2018
Create Date November 06, 2018
Recall Status1 Terminated 3 on June 17, 2021
Recall Number Z-0398-2019
Recall Event ID 81072
510(K)Number K031034  
Product Classification Plate, cranioplasty, preformed, non-alterable - Product Code GXN
Product Biomet Microfixation RapidFlap System
20MM RapidFlap SpinDown Clamp, 12 Pack
Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
Code Information Lot Expiry Date Before: 09/18/2023
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
FDA Determined
Cause 2		 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 Benjamin.Blystone@zimmerbiomet.com .
Quantity in Commerce 6180 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXN and Original Applicant = WALTER LORENZ SURGICAL, INC.
-
-