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U.S. Department of Health and Human Services

Class 1 Device Recall Stryker Custom Cranial Implant Kit

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  Class 1 Device Recall Stryker Custom Cranial Implant Kit see related information
Date Initiated by Firm October 24, 2008
Date Posted December 18, 2008
Recall Status1 Terminated 3 on December 31, 2009
Recall Number Z-0510-2009
Recall Event ID 50172
510(K)Number K043250  
Product Classification Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
Product Stryker Custom Cranial Implant Kit, medium. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00102.

Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.
Code Information All units.
Recalling Firm/
Stryker Craniomaxillofacial Division
750 Trade Centre Way Ste 200
For Additional Information Contact
269-324-5346 Ext. 4258
Manufacturer Reason
for Recall
Lack of assurance of sterility.
FDA Determined
Cause 2
Process control
Action The firm's sales representatives and consignee risk managers, as well as implanting surgeons, were notified individually of the problem via recall letter dated 10/24/08, advised of the risk for serious infections, and instructed to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Direct questions to Stryker's RA/QA Representative 269-324-5346 ext. 4258. The firm issued a press release concerning this recall on 12/23/08.
Quantity in Commerce 322 of all products.
Distribution Nationwide Distribution.
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 = KKY and Original Applicant = STRYKER LEIBINGER