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U.S. Department of Health and Human Services

Class 2 Device Recall ENDOTINE Forehead

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  Class 2 Device Recall ENDOTINE Forehead see related information
Date Initiated by Firm May 23, 2003
Date Posted July 15, 2003
Recall Status1 Terminated 3 on September 23, 2003
Recall Number Z-1002-03
Recall Event ID 26449
Product Classification unknown device name - Product Code ---
Product Drill bits used in ENDOTINE Forehead¿ 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
Code Information Lot Numbers: 00045, 00085 and 00092
Recalling Firm/
Coapt Systems, Inc.
1820 Embarcadero Rd.
Palo Alto CA 94303
For Additional Information Contact Lisa Skrzynecki
Manufacturer Reason
for Recall
During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
FDA Determined
Cause 2
Action On 5/19/03, the firm issued letters via overnight express to all its consignees, informing them of the affected devices and providing instructions on the recall.
Quantity in Commerce 275 units
Distribution These products were distributed nationally to 107 consignees and internationally to 2 consignees via distributors and directly to physicians and/or medical facilities. The total number of devices distributed subject to the removal by lot numbers: lot 00045: 19 units; lot 00085: 94 units; and lot 00092: 160 units. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and/or medical facilities who received the recalled products. There is no known U. S. Government or Canadian distribution.

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.