Z-0922-2012

MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded...

Name: Z-0922-2012 MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded...
Creator: Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
Published: 2011-12-16
License: https://open.fda.gov/license/

Porex Surgical, Inc. / initiated 2011-12-16 / Terminated / root cause: packaging

FDA source

Howmedica Osteonics Corp dba Stryker Craniomaxillofacial began a recall of MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight... on 2011-12-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0922-2012
Status: Terminated
Initiated: 2011-12-16
Posted: 2012-01-27
Terminated: 2012-06-21
Recalling firm: Porex Surgical, Inc.
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.
Product code: FTM Mesh, Surgical
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Catalog number: 81038, Lot Code: F001357

Product code FTM

K040364Class IIMedpor Craniofacial Implants with Embedded Titanium MeshPorex Surgical, Inc. / cleared 2004-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)