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U.S. Department of Health and Human Services

Class 2 Device Recall MEDPOR TITAN

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  Class 2 Device Recall MEDPOR TITAN see related information
Date Initiated by Firm December 16, 2011
Date Posted January 27, 2012
Recall Status1 Terminated 3 on June 21, 2012
Recall Number Z-0922-2012
Recall Event ID 60964
510(K)Number K040364  
Product Classification Mesh, surgical - Product Code FTM
Product MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
Code Information Catalog number: 81038, Lot Code: F001357
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
15 Dart Rd
Newnan GA 30265-1017
For Additional Information Contact Stephanie Fullard
678-479-1610 Ext. 602
Manufacturer Reason
for Recall		 The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch.
FDA Determined
Cause 2		 Packaging process control
Action "Urgent Product Recall" Notification letters and Product Accountability Forms have been sent on January 13, 2012 domestically via FedEx and Internationally via DHL. Customers were informed of the product problem and provided risk mitigation information. Return of the Product Accountability/Acknowledgement form was requested. Questions were directed to 770-254-4423.
Quantity in Commerce 10 units
Distribution Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada.
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 = FTM and Original Applicant = POREX SURGICAL, INC.
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