Tapered SwissPlus® SPWB8Recalls & 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 Tapered SwissPlus dental implant, a screw-shaped root-form implant placed into the jaw to replace a missing tooth. The 47 reports mostly describe implants that had to be removed after failing to heal or becoming infected, along with pain, swelling, bone loss, and abscesses; 42 reports describe injuries and no deaths were reported. A few reports mention the implant breaking or coming apart. There are no recalls naming this device.
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
- 47
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00889024017597), received between Dec 4, 2019 and Aug 7, 2026 — classified as 42 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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 Problem37
- Separation Failure5
- Fracture2
- Detachment of Device or Device Component1
- Patient-Device Incompatibility1
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection23
- Osteolysis21
- Pain15
- No Clinical Signs, Symptoms or Conditions12
- Inflammation5
- Swelling/ Edema4
- Abscess3
- Bone Fracture(s)3
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
The doctor reports that the dental implant failed due to peri-implantitis. Tooth site 26. The doctor reports in the PER that the procedure was not concluded by placing another implant. The doctor reported : Edema.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 50174124 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24835288 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN, EDEMA AND INFLAMMATION ARE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 24606666 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO INFECTION. AN ANTIBIOTIC THERAPY AND IMPLANT REMOVAL WERE NECESSARY TO PREVENT PERMANENT DETERIORATION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 24523614 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #37 WAS REMOVED DUE TO BONE LOSS. NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 24461527 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 24053262 ↗InjuryDec 19, 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 #24 WAS REMOVED DUE TO AN INFECTION. PATIENT HAD PAIN, AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 23853832 ↗InjuryOct 21, 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 NON-INTEGRATION AND PERI-IMPLANTITIS. TOOTH SITE # 27.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23350719 ↗InjuryOct 21, 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 #26 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 23346285 ↗InjuryJun 24, 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 #25 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22323351 ↗InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. DOCTOR FOLLOWED THE SWISSPLUS SURGICAL PROCEDURES TO PLACE THE IMPLANT - SPWB8. AFTER 2 WEEKS, INFECTION WAS HAPPENED TO THE PATIENT. TOOTH SITE 37. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 22198480 ↗InjuryApr 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT PLACED IN POSITION NUMBER #46 FAILED DUE TO AN ALLERGIC REACTION THREE DAYS AFTER ITS PLACEMENT IN THE MOUTH. THE DOCTOR ALSO REPORTS UNBEARABLE PAIN RADIATING FROM THE JAW TO THE EAR.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 21899755 ↗InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A SINUS PERFORATION ON TOOTH SITE # 16-26 DURING IMPLANT PLACEMENT. IMPLANTS WERE REMOVED. A NEW IMPLANTATION IS SCHEDULED FOR (B)(6) 2025.
Patient problems: Sinus Perforation
MAUDE report 21855498 ↗InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A SINUS PERFORATION ON TOOTH SITE # 16-26 DURING IMPLANT PLACEMENT. IMPLANTS WERE REMOVED. A NEW IMPLANTATION IS SCHEDULED FOR (B)(6) 2025.
Patient problems: Sinus Perforation
MAUDE report 21855212 ↗InjuryJan 21, 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. SUDDEN PAIN FOLLOWED BY MOBILITY OF THE IMPLANT WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21195498 ↗InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT HAS BEEN REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND MOBILITY WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21102036 ↗MalfunctionNov 18, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE MOUNT WAS STUCK IN THE IMPLANT, AND IT WAS IMPOSSIBLE TO SEPARATE THEM. PROCEDURE COMPLETED WITH ANOTHER IMPLANT AT TOOTH SITE #46.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707147 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOUR IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS,1 YEAR AFTER THE 5-IMPLANT BRIDGE WAS PLACED. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20628754 ↗InjuryOct 30, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain
MAUDE report 20567330 ↗MalfunctionOct 25, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT BROKEN CAP FOUND DURING RECEIVED SHIPMENT INSPECTION. WE RECEIVED THE SHIPMENT ON OCT 4, 2024. WHEN WE CHECKED THE GOODS, WE FOUND THAT THE LID OF THE PLASTIC OUTER BOX OF ONE SPWB8 (LOT#: 2120010665) WAS NOT CLOSED, SO WE FURTHER CHECKED THE CAP OF THE INNER PLASTIC BOTTLE, AND THEN WE FOUND THAT THE JOINTS OF THE CAP WERE BROKEN IN SEVERAL PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20535506 ↗InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE 26, 2 YEARS AFTER IMPLANTATION. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED AND THE PATIENT WILL RETURN TO REPLACE THE IMPLANT IN OCTOBER.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20181441 ↗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 #17 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19713286 ↗InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT REVMOED DUE TO PERI IMPLANTITIS. INFLAMMATION REPORTED AS A CONSEQUENCE OF THE EVENT. TOOTH LOCATION 25. BONE TYPE III
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18371212 ↗InjuryNov 24, 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: Bone Fracture(s)
MAUDE report 18204424 ↗InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. TOOTH LOCATION 46 AND 47.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17858928 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page