CERTAIN® IIPDTULRecalls & reported problems
ZimVie US Corp LLC · INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG · Class 1
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844868038870), received between Nov 9, 2020 and Jul 10, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Separation Failure10
- Fracture2
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25777899 ↗MalfunctionAug 27, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903525 ↗MalfunctionJul 24, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22585424 ↗MalfunctionNov 18, 2024Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20704308 ↗MalfunctionNov 11, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT ALL OF THE DRIVER WAS GETTING STUCK AND SPINNING IN THE IMPLANT. THE EVENTS OCCURRED DURING DIFFERENT PROCEDURES, BUT THEY WERE ABLE TO COMPLETE THEM WITH NO HARM TO PATIENT OR IMPLANT. THE 3I IMPLANT DRIVER'S TIP HAS BEEN GIVING HIM ISSUES DURING IMPLANT PLACEMENT. AT TIMES, THE DRIVER TIP WILL SPIN IN THE IMPLANT AND OTHER TIMES THE DRIVER TIP WILL GET STUCK IN THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20657961 ↗MalfunctionSep 20, 2024Fracture; Fracture
THE DOCTOR REPORTS THAT THE TIP OF THE DRIVER HAS FRACTURED. PROCEDURE CONCLUDED WITH ANOTHER ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20265135 ↗MalfunctionNov 15, 2023Separation Failure; Separation Failure
IT WAS REPORTED THAT THERE WAS TOO MUCH FRICTION WHEN ENGAGING THE IMPLANT AND THEN IT WAS VERY DIFFICULT TO SEPARATE THE DRIVER FROM THE IMPLANT CONNECTION. CUSTOMER INDICATED THAT THEY SWITCHED OUT THE PLACEMENT TOOL AND WAS ABLE TO PLACE THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18141584 ↗MalfunctionOct 2, 2023Separation Failure; Separation Failure
THE DOCTOR REPORTED THAT DURING THE PROCEDURE, THE IMPLANT AT TOOTH SITE # 26 REMAINED STUCK TO THE DRIVER AND CANNOT BE SEPARATED. THE DOCTOR REPORTED THAT THE TORQUE USED WAS 50 NCM. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER IMPLANT OF THE SAME REFERENCE. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849840 ↗MalfunctionOct 2, 2023Separation Failure; Separation Failure
THE DOCTOR REPORTED THAT DURING THE PROCEDURE, THE IMPLANT AT TOOTH SITE # 46 REMAINED STUCK TO THE DRIVER AND CANNOT BE SEPARATED. THE DOCTOR REPORTED THAT THE TORQUE USED WAS 50 NCM. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER IMPLANT OF THE SAME REFERENCE. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849817 ↗MalfunctionOct 2, 2023Separation Failure; Separation Failure
THE DOCTOR REPORTED THAT DURING THE PROCEDURE, THE IMPLANT AT TOOTH SITE # 35 REMAINED STUCK TO THE DRIVER AND CANNOT BE SEPARATED. THE DOCTOR REPORTED THAT THE TORQUE USED WAS 50 NCM. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER IMPLANT OF THE SAME REFERENCE. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849768 ↗MalfunctionMar 11, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A GUIDED SURGERY, THE DRIVER TIP GOT STUCK IN THE IMPLANT AND BROKE OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13734862 ↗MalfunctionMay 21, 2021Separation Failure; Separation Failure
IT WAS REPORTED THAT BRAND NEW HEX DRIVER GOT STUCK DURING IMPLANT PLACEMENT, NEW IMPLANT PLACED RIGHT AWAY WITH SPARE IMPLANT AND DRIVER. TOOTH LOCATION # 14.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11864596 ↗MalfunctionNov 9, 2020Connection Problem; Connection Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10807961 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.