Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
FDA Recall Z-1002-03 · Posted 2003-07-15
Recalling FirmCoapt Systems, Inc.
Recall StatusTerminated
Date Initiated2003-05-23
Date Terminated2003-09-23
Product Quantity275 units
Reason for Recall
During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.