Tapered SwissPlusRecalls & reported problems across all models
ZimVie US Corp LLC · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 376
- Deaths reported
- 0
- Injuries reported
- 328
- Recalls
- 0
We found 12 models of Tapered SwissPlus by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 376 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2019 and Sep 28, 2026 — classified as 328 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (31 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 SwissPlus problems
Device problems
- Adverse Event Without Identified Device or Use Problem297
- Separation Failure31
- Fracture26
- Unsealed Device Packaging6
- Component Missing5
- Detachment of Device or Device Component4
- Separation Problem3
- Loss of Osseointegration2
Patient problems
- Unspecified Infection223
- Osteolysis202
- Pain89
- No Clinical Signs, Symptoms or Conditions84
- Inflammation57
- Swelling/ Edema19
- No Code Available14
- No Information12
Tapered SwissPlus models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tapered SwissPlus® SPB10IMPLANT, ENDOSSEOUS, ROOT-FORM100 reports
- Tapered SwissPlus® SPWB10IMPLANT, ENDOSSEOUS, ROOT-FORM65 reports
- Tapered SwissPlus® SPB12IMPLANT, ENDOSSEOUS, ROOT-FORM57 reports
- Tapered SwissPlus® SPWB8IMPLANT, ENDOSSEOUS, ROOT-FORM47 reports
- Tapered SwissPlus® SPB8IMPLANT, ENDOSSEOUS, ROOT-FORM40 reports
- Tapered SwissPlus® SPMB10IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- Tapered SwissPlus® SPWB12IMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- Tapered SwissPlus® SPB14IMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- Tapered SwissPlus® SPMB12IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Tapered SwissPlus® SPMB8IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Tapered SwissPlus® SPMB14IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Tapered SwissPlus® SPWB14IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
Recent Tapered SwissPlus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported dvanced buccal bone loss with inflamed gingiva surrounding the implant, tooth site 16, implant removed due to peri-implantitis.Procedure completed with another device
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50915236 ↗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 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a peri-implantitis. Tooth site 46. Patient suffered from inflammation and pain.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50017317 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT A TOOTH SITE #42 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25449566 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25303614 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED FROM PAIN TWO WEEKS AFTER PLACEMENT, WITH RECURRENCE AFTER A COURSE OF ANTIBIOTICS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25284325 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #33 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. THE PATIENT WILL RETURN TO COMPLETE THE PROCEDURE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25218510 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. DOCTOR PERFORMED CURETTAGE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25184261 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25122197 ↗InjuryMay 8, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS. IMPLANT WAS REMOVED. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. BONE TYPE: II.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25120963 ↗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 23, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 25 WAS REMOVED DUE TO EXTENDED PERI-IMPLANTITIS WITH PERSISTENT PARODONTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24964880 ↗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 ↗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 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24699731 ↗
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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