Coapt Systems, Inc. Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
Brand
Coapt Systems, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 00045, 00085 and 00092
Products Sold
Lot Numbers: 00045, 00085 and 00092
Coapt Systems, Inc. is recalling Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303 due to During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
OR
Page updated: Jan 10, 2026