Tapered SwissPlus® SPMB14Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024017481), received between Oct 2, 2020 and Mar 12, 2024 — classified as 3 injuries.
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 Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED IMMEDIATE IMPLANTATION WITH LITTLE PRIMARY STABILITY AND INFECTION AT TOOTH SITE 15.
Patient problems: Unspecified Infection
MAUDE report 18889351 ↗InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT SPMB14 IN TOOTH # 13 (FDI) WAS UNABLE TO PLACE IN OSTEOTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11423306 ↗InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT PLACED AND REMOVED DURING THE SAME SURGERY DUE TO LACK OF PRIMARY STABILITY. BONE GRAFT PERFORMED AND NEW IMPLANT WOULD BE PLACED.
Patient problems: No Information
MAUDE report 10618553 ↗
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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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