Recall Z-0691-2011 ยท JEY Plate, Bone
Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1240, sterile, Manufacturer, INION Oy, Finland.
| Date | Dec 16, 2010 (initiated Apr 14, 2010) |
| Status | Terminated |
| 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) |
| Distribution | Nationwide Distribution: Throughout the US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.