Z-1002-03

Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303

Name: Z-1002-03 Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
Creator: Coapt Systems, Inc.
Published: 2003-05-23
License: https://open.fda.gov/license/

Coapt Systems, Inc. / initiated 2003-05-23 / Terminated

FDA source

Coapt Systems, Inc. began a recall of Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303 on 2003-05-23. The reason FDA records is "During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1002-03
Status: Terminated
Initiated: 2003-05-23
Posted: 2003-07-15
Terminated: 2003-09-23
Recalling firm: Coapt Systems, Inc.
Product: Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
Product code: ---
Reason for recall: During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
FDA 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 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.
Product codes and lots: Lot Numbers: 00045, 00085 and 00092

Product code ---

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)