2.5 mm Inion CPS, 4 hole plate, REF PLT-1023, sterile, Manufacturer, INION Oy, Finland.
FDA device recall Z-0647-2011 · posted 2010-12-16 · Terminated
Recall details
- Recalling firm
- Stryker Craniomaxillofacial Division
- 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.
- Action taken
- 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)
- Root cause
- Other
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 8,631
- Distribution
- Nationwide Distribution: Throughout the US
- Date initiated
- 2010-04-14
- Date posted
- 2010-12-16
- Date terminated
- 2012-06-06
- Location
- Portage, MI
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