Tapered Screw-Vent Implant SystemRecalls & reported problems across all models
ZimVie US Corp LLC · 28 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 105
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 28 models of Tapered Screw-Vent Implant System by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 105 adverse event reports in the FDA's MAUDE database, received between Jan 30, 2020 and Sep 18, 2026 — classified as 19 injuries, 86 malfunctions.
The most frequently reported specific device problem is “Fracture” (37 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 Tapered Screw-Vent Implant System problems
Device problems
- Fracture37
- Unintended Movement36
- Positioning Failure23
- Mechanical Problem5
- Separation Failure3
- Separation Problem2
- Component Missing1
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- No Information7
- Pain3
- Inflammation2
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Discomfort1
- No Code Available1
Tapered Screw-Vent Implant System models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tapered Screw-Vent® Implant System HC455ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS15 reports
- Tapered Screw-Vent® Implant System TAC2IMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- Tapered Screw-Vent Implant System HC445ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS8 reports
- Tapered Screw-Vent® Implant System HLA4GIMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- Tapered Screw-Vent® Implant System 15AT312ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS6 reports
- Tapered Screw-Vent® Implant System 15AT323ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- Tapered Screw-Vent® Implant System 30AT424ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- Tapered Screw-Vent® Implant System TAC3IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Tapered Screw-Vent® Implant System TACW2IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Tapered Screw-Vent® Implant System ZRA341SABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- Tapered Screw-Vent® Implant System 15AT423ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- Tapered Screw-Vent® Implant System HC563ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- Tapered Screw-Vent® Implant System HC565ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- Tapered Screw-Vent® Implant System 15AT334ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Tapered Screw-Vent® Implant System 30AT335ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Tapered Screw-Vent® Implant System 30AT346ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Tapered Screw-Vent® Implant System 30AT446ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Tapered Screw-Vent® Implant System AH20SIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Tapered Screw-Vent® Implant System HC457ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Tapered Screw-Vent® Implant System HC465ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Tapered Screw-Vent® Implant System TAC1ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Tapered Screw-Vent® Implant System ACTTIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Tapered Screw-Vent® Implant System BAC2IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Tapered Screw-Vent® Implant System BAC6IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Tapered Screw-Vent® Implant System HLA3GIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Tapered Screw-Vent® Implant System HLA5GIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Tapered Screw-Vent® Implant System TACW5IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Tapered Screw-Vent® Implant System ZRA461AABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
Recent Tapered Screw-Vent Implant System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Fracture
Doctor reported screw fracture. Patient came referring mobility on bridge supported by implant, doctor noticed that multi-unit screw of one of the abutments of the 3 piece-bridge fractured. Procedure was completed with a new multi-unit of height 35.2 mm. Tooth site 14.Abutment placement date: (b)(6) 2018,Abutment removal date: (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816767 ↗MalfunctionApr 10, 2026Fracture
IT WAS REPORTED THAT ABUTMENTS SCREW WAS FRACTURED. TOOTH LOCATION # 45 AND 47.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843133 ↗MalfunctionApr 10, 2026Fracture
IT WAS REPORTED THAT ABUTMENTS SCREW WAS FRACTURED. TOOTH LOCATION # 45 AND 47.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843035 ↗MalfunctionMar 26, 2026Fracture
IT WAS REPORTED THAT THE ABUTMENT FRACTURED AT THE SCREW PORTION IN THE IMPLANT BUT WAS RETRIEVED. THE PATIENT HAS BEEN SCHEDULED TO REPLACE THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699292 ↗MalfunctionMar 20, 2026Fracture
THE DOCTOR REPORTS THAT THE DENTAL ABUTMENT LOCATED IN POSITION NUMBER 11 FAILED BECAUSE IT FRACTURED AT THE SCREW. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647723 ↗MalfunctionMar 12, 2026Fracture
DOCTOR REPORTED THAT PROSTHESIS AT TOOTH SITE 42 WAS LOOSE, ON THE X-RAY IT WAS NOTICED THAT ABUTMENT SCREW WAS FRACTURED. A NEW TAC2 WAS PLACED. PLACEMENT DATE: (B)(6) 2024, REMOVED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577683 ↗MalfunctionFeb 27, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468971 ↗InjuryFeb 26, 2026Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461869 ↗MalfunctionFeb 13, 2026Fracture
IT WAS REPORTED THAT THE PATIENT BROUGHT BACK THE FRACTURED RESTORATION (ABUTMENT FROM TOOTH SITE #44) WITH THE CROWN IN HIS HAND. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330917 ↗MalfunctionFeb 4, 2026Fracture
IT WAS REPORTED, THAT TWO TAC1 ABUTMENTS FROM THE SAME BRIDGE (#24 - #25) WERE REPLACED DUE TO BEING FRACTURED: IN ONE ABUTMENT, THE SCREW FRACTURED INSIDE THE IMPLANT (THE FRACTURED FRAGMENT WAS REMOVED AND THE IMPLANT WAS NOT AFFECTED), AND IN THE OTHER, THE PLATFORM BASE WAS FRACTURED. ABUTMENTS WERE PLACED ON (B)(6) 2018 AND REMPVED ON (B)(6) 2025. BRIDGE REMAINED INTACT. THE PROCEDURE WAS COMPLETED USING TWO NEW TAC1 ABUTMENTS. THIS REPORT REFERS TO ABUTMENT FRACTURED AT THE SCREW PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256518 ↗MalfunctionJan 15, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 HAS A FRACTURED ZRA341S. IMPLANT IS IN PATIENT'S MOUTH WITH OUT ANY ISSUES. ADDITIONAL APPOINTMENT REQUIRED TO PLACE NEW ZRA341S. SYMPTOMS AS A RESULT OF THE EVENT: NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087303 ↗MalfunctionDec 30, 2025Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920133 ↗MalfunctionDec 30, 2025Unintended Movement; Unintended Movement
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920109 ↗MalfunctionDec 5, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23725996 ↗MalfunctionOct 30, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23430009 ↗
Other ZimVie US Corp LLC products
- Tapered Screw-Vent131 models · 13,236 reports · 4 recalls
- OSSEOTITE CERTAIN74 models · 1,891 reports · 1 recall
- TSX Implants28 models · 1,279 reports
- OSSEOTITE73 models · 894 reports
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 reports
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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