MEDPOR TITAN Cranial Temporal with Template - Right… recallZ-0922-2012 · Howmedica Osteonics Corp dba Stryker Craniomaxillofacial · initiated Dec 16, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Howmedica Osteonics Corp dba Stryker Craniomaxillofacial or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Packaging process control
What the company is doing
"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.
Recall details
- Recall number
- Z-0922-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 16, 2011
- Posted by the FDA
- Jan 27, 2012
- Recalling firm
- Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
- Quantity
- 10 units
- Product code
- FTM
- FDA submissions
- K040364
- Distribution
- Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada.
Product description
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 (models, lots, serial numbers)
Catalog number: 81038, Lot Code: F001357
Other devices under the same FDA submission
4 devices cleared under K040364 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- MEDPOR TITAN 81033Stryker Leibinger GmbH & Co. KG · Mesh, surgical2 reports
- MEDPOR TITAN 81024Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 report
- MEDPOR TITAN 81029Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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