Date Initiated by Firm | April 14, 2010 |
Date Posted | December 16, 2010 |
Recall Status1 |
Terminated 3 on June 06, 2012 |
Recall Number | Z-0630-2011 |
Recall Event ID |
55861 |
510(K)Number | K010351 K010352 K020266 |
Product Classification |
Plate, bone - Product Code JEY
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Product | 1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland. |
Code Information |
Lot numbers of 0700000and above. |
Recalling Firm/ Manufacturer |
Stryker Craniomaxillofacial Division 750 Trade Centre Way Ste 200 Portage MI 49002-0482
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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) |
Quantity in Commerce | 8,631 |
Distribution | Nationwide Distribution: Throughout the US |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = JEY
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