FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp dba Stryker Craniomaxillofacial: 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.
- Recall number
- Z-0922-2012
- Recalling firm
- Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
- 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.
- Status
- Terminated
- Initiated
- 2011-12-16
- Posted
- 2012-01-27
- Terminated
- 2012-06-21
- Reason
- 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
- 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
- 10 units
- Distribution
- Worldwide Distribution - USA, the state of Michigan, and the countries of Australia and Canada.
- Lot, serial or model codes
- Catalog number: 81038, Lot Code: F001357
- 510(k) numbers
- ["K040364"]
- PMA numbers
- not on file
- Product code
- FTM
- Firm FEI
- 1000131961
- Firm city
- Newnan
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28