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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 QuickFlapsee related information
Date Initiated by FirmJune 22, 2018
Create DateAugust 29, 2018
Recall Status1 Terminated 3 on July 08, 2019
Recall NumberZ-2912-2018
Recall Event ID 80371
510(K)NumberK120352 
Product Classification Plate, cranioplasty, preformed, alterable - Product Code GWO
ProductAXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Code Information 1000201620, 1000203741, 1000215161, 1000221838, 1000224226, 1000230171, 1000232403, 1000233774, 1000235432, 1000236133, 1000238416, 1000245179, 1000251379, 1000254404, 1000255711, 1000257449, 1000258651, 1000258652, 1000259409, 1000260283, 1000260284, 1000260285, 1000261025, 1000261026, 1000261689, 1000261690, 1000261691, 1000263498, 1000263499, 1000263500, 1000263501, 1000263502, 1000264407, 1000264408, 1000265423, 1000265424, 1000266165, 1000266166, 1000266167, 1000267009, 1000267010, 1000267748, 1000267749, 1000267750, 1000268573, 1000268574, 1000269518, 1000269519, 1000270162, 1000270163, 1000270837, 1000270838, 1000285715, 1000287395, 1000289257, 1000201620, 1000288210, 1000290246, 1000291275, 1000292116, 1000294081
Recalling Firm/
Manufacturer		 Stryker Leibinger GmbH & Co. KG
Botzinger Str. 41
Freiburg Im Breisgau Germany
For Additional Information ContactJulie 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
ActionURGENT 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 Commerce22,831 total
DistributionUS distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GWO
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