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.
FDA Recall Z-0922-2012 · Posted 2012-01-27
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Recalling FirmHowmedica Osteonics Corp dba Stryker Craniomaxillofacial
Recall StatusTerminated
Product CodeFTM
Date Initiated2011-12-16
Date Terminated2012-06-21
Product Quantity10 units
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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