Class 2 Device Recall QuickFlap

• Date Initiated by Firm: June 22, 2018
• Create Date: August 29, 2018
• Recall Status: Terminated 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: 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