BioHorizons TD-2509Recalls & reported problems
Biohorizons Implant Systems, Inc · 2.5mm Tapered Surgical Drill, Grey, 9mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847236022006), received between Mar 7, 2024 and Aug 25, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (10 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate10
- Loss of Osseointegration1
Patient problems
- Insufficient Information10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Failure to Osseointegrate
InjuryMay 21, 2026Failure to Osseointegrate
InjuryApr 7, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 2024Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
Other Accessories, Implant, Dental, Endosseous devices
- N/A 68015189Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous388 reports
- N/A 68015191Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous319 reports
- N/A 68015193Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous283 reports
- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
- N/A 68015188Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous185 reports
- N/A 68015192Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous159 reports
- N/A 68015190Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous147 reports
- NobelReplace® 37045Nobel Biocare AB · Accessories, implant, dental, endosseous2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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