Tapered SwissPlus® SPWB12Recalls & 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
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024017573), received between Jul 15, 2021 and Apr 23, 2026 — classified as 14 injuries, 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (1 report).
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 Problem13
- Component Missing1
- Fracture1
Patient problems
- Osteolysis11
- Unspecified Infection11
- No Clinical Signs, Symptoms or Conditions3
- Abscess2
- Pain1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24520564 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #16, #17 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22685414 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #16, #17 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22685336 ↗InjuryAug 1, 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 #36.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22685149 ↗InjuryJun 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 16 OBSERVED DURING THE CLINICAL PROCEDURE. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT. LOSS OF INTEGRATION WAS ALSO REPORTED. NO IMPACT ON THE PATIENT WAS REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22165149 ↗InjuryApr 24, 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 BONE LOSS. TOOTH SITE # 24.
Patient problems: Osteolysis
MAUDE report 21898101 ↗MalfunctionJul 18, 2024Component Missing; Component Missing
IT IS REPORTED THAT UPON OPENING THE IMPLANT CASE, THERE WAS NO IMPLANT INSIDE, PACKAGE WAS COMPLETELY EMPTY. SURGERY WAS COMPLETED USING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19769789 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 45 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. XENOGRAFT WAS APPLIED AND NEW IMPLANTS WILL BE PLACED IN 5-6 MONTHS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18902978 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 45 AND 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. XENOGRAFT WAS APPLIED AND NEW IMPLANTS WILL BE PLACED IN 5-6 MONTHS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18902828 ↗InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION WITH PAIN .
Patient problems: Pain; Unspecified Infection
MAUDE report 18212444 ↗InjuryJun 13, 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: Abscess; Osteolysis; Unspecified Infection
MAUDE report 17117688 ↗InjuryAug 31, 2021Adverse 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; Unspecified Infection
MAUDE report 12392345 ↗InjuryJul 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT TOOTH SITE #14 LACKED PRIMARY STABILITY AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12186124 ↗InjuryJul 15, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12173324 ↗
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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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