Z5c Z5c-40-12Recalls & reported problems
Z-Systems AG · Two-piece root-form dental implant made of Zirconia Familiy Z5c Size Z5m-40-12 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5c zirconia dental implant is a two-piece root-form implant. Most of the 45 reports describe the implant failing to bond with the jawbone or later losing that bond, sometimes breaking under heavy chewing forces, along with tissue injury around the site. There were 42 injuries and no deaths, and 3 malfunctions. No recalls name 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
- 45
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 07640166760429), received between Sep 10, 2020 and May 18, 2026 — classified as 42 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (26 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
- Failure to Osseointegrate26
- Loss of Osseointegration17
- Fracture2
Patient problems
- Unspecified Tissue Injury41
- No Clinical Signs, Symptoms or Conditions3
- Tissue Damage1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Fracture
MalfunctionFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387429 ↗MalfunctionMar 17, 2025Fracture; Fracture
FRACTURE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616417 ↗InjuryAug 28, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 28, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryMar 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
FRACTURE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 16288670 ↗InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 29, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 29, 2022Loss of Osseointegration; Loss of Osseointegration
FRACTURE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 15876462 ↗InjuryAug 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 9, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryNov 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 11, 2021Loss of Osseointegration; Loss of Osseointegration
FRACTURE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 12794077 ↗InjuryNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
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.
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