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U.S. Department of Health and Human Services

Class 2 Device Recall Inion CPS

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  Class 2 Device Recall Inion CPS see related information
Date Initiated by Firm April 14, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on June 06, 2012
Recall Number Z-0696-2011
Recall Event ID 55861
Product Classification Plate, bone - Product Code JEY
Product 2.0 mm Inion CPS, 2.0 x 11 mm screw, REF SCR-1285, 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 2
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
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.
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