Class 2 Device Recall Inion CPS

• Date Initiated by Firm: April 14, 2010
• Date Posted: December 16, 2010
• Recall Status: Terminated on June 06, 2012
• Recall Number: Z-0638-2011
• Recall Event ID: 55861
• Product Classification: Plate, bone - Product Code JEY
• Product: 1.5 mm Inion CPS, C-plate, 7 holes, REF PLT-1008, sterile, Manufacturer, INION Oy, Finland.
• Code Information: Lot numbers of 0700000 and above.
• Recalling Firm/ Manufacturer: Stryker Craniomaxillofacial Division; 750 Trade Centre Way; Ste 200; Portage MI 49002-0482
• For Additional Information Contact: 877-534-2464
• Manufacturer 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.
• FDA Determined 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 in Commerce: 8,631 all products
• Distribution: Nationwide Distribution: Throughout the US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.