Tapered Screw-Vent® SRTRecalls & reported problems
ZimVie US Corp LLC · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024017603), received between Oct 19, 2023 and Mar 16, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2026Fracture
IT WAS REPORTED THAT THE SRT WAS USED TO REMOVE A FRACTURED SCREW INSIDE THE IMPLANT. WHILE TRYING TO REMOVE THE SCREW THE SRT FRACTURED AT THE TIP. SRT FRACTURED AT THE TIP WHERE IT ENGAGES WITH THE SCREW. PART OF THE FRACTURED SCREW IS STILL IN THE IMPLANT. IMPLANT IS STILL IN PATIENT'S MOUTH WITHOUT ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604563 ↗MalfunctionMar 19, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SCREW REMOVAL TOOL FRACTURED DURING A PROCEDURE AND THE PROCEDURE WAS UNABLE TO BE COMPLETED. THE PART OF THE INSTRUMENT THAT FRACTURED IS STUCK IN THE IMPLANT AND COULD NOT BE RETRIEVED. THE IMPLANT WAS NOT REMOVED AND THE PATIENT STILL HAS THE IMPLANT IN THE MOUTH WITH THE BROKEN TOOL PORTION IN PLACE, WITH THE ACCESS HOLE COVERED BY A TEMPORARY RESTORATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21645555 ↗MalfunctionApr 11, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE REMOVING A STRIPPED SCREW THE SRT TIP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19092027 ↗MalfunctionOct 21, 2023Fracture; Fracture
UPON FOLLOW UP, THE LOT NUMBER WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17981988 ↗MalfunctionOct 19, 2023Fracture; Fracture
IT WAS REPORTED THAT WHILE REMOVING A STRIPPED SCREW, THE SCREW REMOVAL TOOL (SRT) TIP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17966310 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.