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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