Z-0707-2011

2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy, Finland

Name: Z-0707-2011 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy, Finland
Creator: Stryker Craniomaxillofacial Division
Published: 2010-04-14
License: https://open.fda.gov/license/

Stryker Craniomaxillofacial Division / initiated 2010-04-14 / Terminated / root cause: labeling and UDI

FDA source

Stryker Craniomaxillofacial Division began a recall of 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy, Finland on 2010-04-14. The reason FDA records is "Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0707-2011
Status: Terminated
Initiated: 2010-04-14
Posted: 2010-12-16
Terminated: 2012-06-06
Recalling firm: Stryker Craniomaxillofacial Division
Product: 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy, Finland.
Product code: JEY Plate, Bone
Reason for recall: Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
Root cause tag: labeling and UDI
FDA 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)
Distribution: Nationwide Distribution: Throughout the US
Product codes and lots: Lot numbers of 0700000 and above.

Product code JEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)