DS OmniTaperRecalls & reported problems across all models
Dentsply Implants Manufacturing GmbH · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,128
- Deaths reported
- 0
- Injuries reported
- 2,103
- Recalls
- 0
We found 32 models of DS OmniTaper by Dentsply Implants Manufacturing GmbH in the FDA's device registry (GUDID). Together they are named in 2,128 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2023 and Sep 30, 2026 — classified as 2,103 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,815 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DS OmniTaper problems
Device problems
- Failure to Osseointegrate1,815
- Loss of Osseointegration233
- Fracture32
- Off-Label Use14
- Malposition of Device11
- Separation Failure9
- Adverse Event Without Identified Device or Use Problem7
- Insufficient Device Problem Information5
Patient problems
- Failure of Implant2,040
- Unspecified Infection392
- Osteolysis231
- Inflammation122
- No Clinical Signs, Symptoms or Conditions43
- Inadequate Osseointegration42
- Pocket Erosion42
- Implant Pain21
DS OmniTaper models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DS OmniTaper 68011150IMPLANT, ENDOSSEOUS, ROOT-FORM381 reports
- DS OmniTaper 68011149IMPLANT, ENDOSSEOUS, ROOT-FORM282 reports
- DS OmniTaper 68011144IMPLANT, ENDOSSEOUS, ROOT-FORM209 reports
- DS OmniTaper 68011148IMPLANT, ENDOSSEOUS, ROOT-FORM182 reports
- DS OmniTaper 68011143IMPLANT, ENDOSSEOUS, ROOT-FORM167 reports
- DS OmniTaper 68011155IMPLANT, ENDOSSEOUS, ROOT-FORM166 reports
- DS OmniTaper 68011156IMPLANT, ENDOSSEOUS, ROOT-FORM143 reports
- DS OmniTaper 68011151IMPLANT, ENDOSSEOUS, ROOT-FORM130 reports
- DS OmniTaper 68011145IMPLANT, ENDOSSEOUS, ROOT-FORM109 reports
- DS OmniTaper 68011154IMPLANT, ENDOSSEOUS, ROOT-FORM107 reports
- DS OmniTaper 68011140IMPLANT, ENDOSSEOUS, ROOT-FORM67 reports
- DS OmniTaper 68011157IMPLANT, ENDOSSEOUS, ROOT-FORM47 reports
- DS OmniTaper 68011160IMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- DS OmniTaper 68011161IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- DS OmniTaper 68011146IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- DS OmniTaper 68011152IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- DS OmniTaper 68011141IMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- DS OmniTaper 68011158IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- DS OmniTaper 68011162IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- DS OmniTaper 68015130Accessories, implant, dental, endosseous5 reports
- DS OmniTaper 68015129Accessories, implant, dental, endosseous4 reports
- DS OmniTaper 68011142IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- DS OmniTaper 68012166Abutment, implant, dental, endosseous2 reports
- DS OmniTaper 68015086Accessories, implant, dental, endosseous1 report
- DS OmniTaper 68015087Accessories, implant, dental, endosseous1 report
- DS OmniTaper 68015080Accessories, implant, dental, endosseous1 report
- DS OmniTaper 68015082Accessories, implant, dental, endosseous1 report
- DS OmniTaper 68015083Accessories, implant, dental, endosseous1 report
- DS OmniTaper 68015084Accessories, implant, dental, endosseous1 report
- DS OmniTaper 68017124Accessories, implant, dental, endosseous1 report
- DS OmniTaper 68011163IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- DS OmniTaper 68011164IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent DS OmniTaper adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50952832 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50952797 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50952748 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952731 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50952674 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50952610 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50947076 ↗MalfunctionSep 30, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946555 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50945224 ↗MalfunctionSep 30, 2026Physical Resistance/Sticking
It was reported that single-use drills cracked during use or could not be removed from the contra-angle handpiece.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943975 ↗MalfunctionSep 30, 2026Physical Resistance/Sticking
It was reported that single-use drills cracked during use or could not be removed from the contra-angle handpiece.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943907 ↗MalfunctionSep 30, 2026Physical Resistance/Sticking
It was reported that single-use drills cracked during use or could not be removed from the contra-angle handpiece.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943845 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938858 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50938798 ↗MalfunctionSep 29, 2026Difficult to Insert
It was reported that the implant at tooth No. 18 could not be completely inserted. The surgery was successfully completed using another implant.
Patient problems: Insufficient Information
MAUDE report 50931700 ↗
Other Dentsply Implants Manufacturing GmbH products
- ASTRA TECH Implant System EV177 models · 37,200 reports
- ASTRA TECH Implant System166 models · 27,749 reports
- ANKYLOS112 models · 20,917 reports
- XiVE62 models · 12,456 reports
- DS PrimeTaper61 models · 6,897 reports
- DS Implants44 models · 145 reports
- FRIADENT23 models · 55 reports
- FRIALIT12 models · 35 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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