NA DTN3215Recalls & reported problems
ZimVie US Corp LLC · DISPOSABLE TWIST DRILL, NON-HUBBED 3.25MM(D) X 15MM(L) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844868002741), received between Oct 22, 2021 and Oct 22, 2021 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SALES REP CALLED FROM DOCTORS OFFICE AND STATED THAT WHILE PLACING THE IMPLANT THE BUCCAL PLATE FRACTURED, SO THEY WERE UNABLE TO PLACE THE IMPLANT. SITE WAS GRAFTED.
Patient problems: Bone Fracture(s)
MAUDE report 12682477 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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