GemLock® RHD2.5Recalls & reported problems
ZimVie US Corp LLC · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024016705), received between Jul 1, 2022 and May 14, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Detachment of Device or Device Component1
- Mechanical Problem1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Separation Failure
DOCTOR REPORTED THAT DEVICE GOT STUCK WHEN INSERTING IMPLANT, THERE IS FRACTURE RISK.PROCEDURE WAS COMPLETED USING ANOTHER A SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25170366 ↗MalfunctionApr 10, 2026Fracture
IT WAS REPORTED THAT THE LATCHLOCK DRIVER FRACTURED AT THE TIP DURING THE IMPLANT PLACEMENT. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843268 ↗MalfunctionApr 10, 2026Fracture; Mechanical Problem
IT WAS REPORTED THAT THE LATCHLOCK DRIVER FRACTURED AT THE TIP DURING THE IMPLANT PLACEMENT. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843175 ↗MalfunctionSep 5, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE DRIVER BROKE AT THE TIP. THE PATIENT IS FINE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977347 ↗MalfunctionAug 21, 2025Fracture; Fracture
IT WAS REPORTED THAT DRIVER BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22865493 ↗MalfunctionJul 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE IMPLANT BECAME DETACHED FROM THE DRIVER. THE DOCTOR CONFIRMS THAT THE DENTAL SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14883832 ↗
Other ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS devices
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- 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
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- N/A 68015192Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous159 reports
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- NobelReplace® 37045Nobel Biocare AB · Accessories, implant, dental, endosseous2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.