Recall Z-1002-03 ยท ---
Coapt Systems, Inc.
Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
| Date | Jul 15, 2003 (initiated May 23, 2003) |
| Status | Terminated |
| Reason | During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury. |
| Root cause | 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 | 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 000 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.