Tapered SwissPlus® SPB12Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Tapered SwissPlus (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie SwissPlus SPB12 endosseous dental implant, a screw-shaped fixture placed into the jawbone to support a tooth. Most of the 60 reports describe implants that failed to heal in or that later loosened, with bone loss and peri-implantitis infection around the site, and several that fractured or would not separate from its mount and could not be placed. Reports mention 49 injuries and no deaths. No recalls name this device, and report numbers are steady.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00889024017184), received between Mar 24, 2020 and May 7, 2026 — classified as 46 injuries, 11 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem40
- Fracture5
- Separation Failure5
- Unsealed Device Packaging4
- Packaging Problem2
- Separation Problem1
Patient problems
- Unspecified Infection33
- Osteolysis31
- No Clinical Signs, Symptoms or Conditions13
- Pain12
- Inflammation7
- No Code Available7
- Discomfort3
- Nerve Damage1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. TOOTH LOCATION 44.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25111317 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO A BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24885393 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS AT TOOTH SITE #46. IMPLANT WAS REMOVED. NO OTHER IMPACT ON THE PATIENT REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24615077 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #33 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24521053 ↗MalfunctionFeb 13, 2026Separation Failure
IT WAS REPORTED THAT THE IMPLANT COULD NOT BE SEPARATED FROM THE MOUNT; THEREFORE, IT WAS NOT IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330774 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #47 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24307273 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23816511 ↗InjuryDec 5, 2025Adverse 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: Nerve Damage; Pain
MAUDE report 23725866 ↗InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #43 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23427515 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PERI-IMPLANTITIS, AND LOSS OF INTEGRATION; AT IMPLANT IN TOOTH SITE #46, AND THE IMPLANT WAS REMOVED. SITE PRESENTED INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23348662 ↗InjuryAug 4, 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 POSITION NUMBER #43 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22698164 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE #15.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22680988 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE #43.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22518458 ↗InjuryJul 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE #43.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22488386 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 43 OBSERVED DURING THE CLINICAL PROCEDURE. IMPLANT WAS REMOVED. THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS REPORTED ON THE PATIENT: INFECTION, ABSCESS, BONE LOSS, PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22456860 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 32 FELL DOWN DUE TO PERI-IMPLANTITIS AND PATIENT BROUGHT IT ON HER HAND.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21983168 ↗InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #15 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21468278 ↗InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH LOCATION 26 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21197007 ↗InjuryDec 9, 2024Adverse 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; Pain; Unspecified Infection
MAUDE report 20876514 ↗InjuryDec 9, 2024Adverse 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; Pain; Unspecified Infection
MAUDE report 20876451 ↗InjuryJul 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 19770622 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #16 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19713336 ↗InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 21 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: III.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19399893 ↗InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #46 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: III THE DOCTOR REPORTED : PAIN + BRUXISM + DIABETES + OSTEOPOROSIS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19259154 ↗InjuryApr 25, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain; Swelling/ Edema
MAUDE report 19181485 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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