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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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 3 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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

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