FDA Medical Device Recalls (openFDA)
Stryker Craniomaxillofacial Division: 2.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile, Manufacturer, INION Oy, Finland.
- Recall number
- Z-0706-2011
- Recalling firm
- Stryker Craniomaxillofacial Division
- Product
- 2.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile, Manufacturer, INION Oy, Finland.
- Status
- Terminated
- Initiated
- 2010-04-14
- Posted
- 2010-12-16
- Terminated
- 2012-06-06
- Reason
- Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
- Root cause
- Other
- Action
- Stryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 14, 2010. The notice informed users of the change in the instructions for use (IFU), and included a copy of the revised IFU. The consignees were informed that the affected product does not need to be returned. Stryker can be contacted about this action at 877-534-2464 (option "Regulatory Affairs", reference Product Field Action #2009-445)
- Quantity
- not on file
- Distribution
- Nationwide Distribution: Throughout the US
- Lot, serial or model codes
- Lot numbers of 0700000 and above.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 3005101424
- Firm city
- Portage
- Firm state
- MI
- 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