Date Initiated by Firm |
August 22, 2018 |
Create Date |
November 06, 2018 |
Recall Status1 |
Terminated 3 on June 17, 2021 |
Recall Number |
Z-0394-2019 |
Recall Event ID |
81072 |
510(K)Number |
K031034
|
Product Classification |
Plate, cranioplasty, preformed, non-alterable - Product Code GXN
|
Product |
Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 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 |
11736 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
|
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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.
|