2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1241, sterile, Manufacturer, INION Oy, Finland.
This recall has been terminated (originally issued December 16, 2010).
- Recall Initiated
- April 14, 2010
- Posted
- December 16, 2010
- Terminated
- June 6, 2012
- Recall Number
- Z-0692-2011
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution: Throughout the US
Lot / Code Info
Lot numbers of 0700000 and above.
Root Cause
Other
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)
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