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 ---
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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/ Manufacturer |
Coapt Systems, Inc. 1820 Embarcadero Rd. Palo Alto CA 94303
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For Additional Information Contact |
Lisa Skrzynecki 650-331-2405
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Manufacturer Reason for Recall |
During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
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FDA Determined Cause 2 |
Other |
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. |
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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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