LOCATOR R-Tx 30700-03Recalls & reported problems
Zest Anchors, LLC · LOCATOR R-Tx Abutment for 3.6mm EV Internal Conical Connection Implant, Denstply, 3mm Cuff · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840481110696), received between Oct 4, 2023 and Oct 4, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2023Loss of Osseointegration; Loss of Osseointegration
FRACTURE OF 2 LOCATORS. THE FRAGMENTS COULD NOT BE REMOVED, THEREFORE EXPLANTATION OF 2 ASTRA EV OS IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17869680 ↗InjuryOct 4, 2023Loss of Osseointegration; Loss of Osseointegration
FRACTURE OF 2 LOCATORS. THE FRAGMENTS COULD NOT BE REMOVED, THEREFORE EXPLANTATION OF 2 ASTRA EV OS IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17869679 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
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- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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