SwissPlusRecalls & reported problems across all models
ZimVie US Corp LLC · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 10 models of SwissPlus by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2020 and Mar 12, 2026 — classified as 23 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. 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 SwissPlus problems
Device problems
- Adverse Event Without Identified Device or Use Problem23
- Fracture2
- Unintended Movement2
- Positioning Failure1
Patient problems
- Osteolysis17
- Unspecified Infection14
- Pain12
- No Clinical Signs, Symptoms or Conditions5
- Inflammation3
- No Information1
SwissPlus models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SwissPlus® OPB8IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- SwissPlus® OPB10IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- SwissPlus® OPB12IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- SwissPlus® OPB14IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- SwissPlus® OPBAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- SwissPlus® OPACTABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- SwissPlus® OPACT3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- SwissPlus® OPSCLIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- SwissPlus® OPWB10IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- SwissPlus® OPWB12IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent SwissPlus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Fracture
DOCTOR REPORTED THAT PATIENT WENT TO CLINIC FOR A CHECK-UP AND DOCTOR NOTICED THAT ABUTMENT SCREW AT TOOTH SITE 33 WAS FRACTURED. A NEW OPACT WAS PLACED. PLACEMENT DATE: (B)(6) 2024, REMOVED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580087 ↗MalfunctionMar 12, 2026Fracture
DOCTOR REPORTED THAT PATIENT WENT TO CLINIC BECAUSE PROSTHESIS WAS MOVING, SCREW FRACTURED AT TOOTH SITE 17. A NEW OPACT3 WAS PLACED. PLACEMENT DATE: (B)(6) 2022, REMOVED ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577719 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24012476 ↗InjuryNov 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23627286 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN TOOTH SITE #24 FAILED DUE TO INFECTION. ANTIBIOTIC WAS PRESCRIBED AND THE DOCTOR WILL WAIT FOR REGENERATION. THE DOCTOR REPORTED PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 23358402 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN TOOTH SITE #24 FAILED DUE TO INFECTION. ANTIBIOTIC WAS PRESCRIBED AND THE DOCTOR WILL WAIT FOR REGENERATION. THE DOCTOR REPORTED PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 23358263 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN TOOTH SITE #24 FAILED DUE TO INFECTION. ANTIBIOTIC WAS PRESCRIBED AND THE DOCTOR WILL WAIT FOR REGENERATION. THE DOCTOR REPORTED PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 23358145 ↗InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED AT TOOTH SITE #36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22814123 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN UNKNOWN POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED THAT THE PATIENT HAD PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22689867 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN UNKNOWN POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED THAT THE PATIENT HAD PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22689796 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN UNKNOWN POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED THAT THE PATIENT HAD PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22689658 ↗InjuryJun 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22208209 ↗MalfunctionNov 20, 2023Unintended Movement; Unintended Movement
NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18173396 ↗MalfunctionSep 18, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED THAT LOOSENESS SEEMS TO OCCUR WITH THIS ABUTMENT SCREW ABOUT THREE (3) DAYS BEFORE IT FRACTURES. TOOTH SITE #5. THIS EVENT CAPTURES SCREW LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17763735 ↗InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 16250369 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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