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U.S. Department of Health and Human Services

Class 2 Device Recall QuickFlap

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  Class 2 Device Recall QuickFlap see related information
Date Initiated by Firm June 22, 2018
Create Date August 29, 2018
Recall Status1 Terminated 3 on July 08, 2019
Recall Number Z-2899-2018
Recall Event ID 80371
510(K)Number K120352  
Product Classification Plate, cranioplasty, preformed, alterable - Product Code GWO
Product QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S

The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Code Information 1000193584
Recalling Firm/
Manufacturer		 Stryker Leibinger GmbH & Co. KG
Botzinger Str. 41
Freiburg Im Breisgau Germany
For Additional Information Contact Julie Brown
269-389-3946
Manufacturer Reason
for Recall		 After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
FDA Determined
Cause 2		 Package design/selection
Action URGENT MEDICAL DEVICE RECALL letters dated 6/22/18 were sent to customers with the following requested actions to be taken: 1. Please inform users of this Medical Device Removal and pass this notice to all appropriate individuals within your organization. 2. Return all affected products available at your location to: Stryker CMF Attn: Recall Coordinator 6300 Sprinkle Rd Portage, MI 49002 REF: PFA #1739180 Or, Contact Stryker Customer Service and refer to PFA #1739180 with any questions about returning the product to us. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: (877) 648-7114 or email a copy to CMF-custserv@stryker.com. 4. Keep a copy of the completed and executed Customer response Form for your records.
Quantity in Commerce 22,831 total
Distribution US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
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 = GWO and Original Applicant = Stryker
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