Z5m Z5m-40-08Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-40-08 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m zirconia dental implant has 86 adverse event reports: 73 injuries, 13 malfunctions and no deaths. The reports mostly describe the implant not bonding with the jawbone, or losing that bond, and most report unspecified tissue injury. 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
- 86
- Deaths reported
- 0
- Injuries reported
- 73
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 07640166760023), received between Aug 31, 2020 and Aug 26, 2026 — classified as 73 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (71 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 Osseointegrate71
- Loss of Osseointegration15
Patient problems
- Unspecified Tissue Injury70
- No Clinical Signs, Symptoms or Conditions8
- Inflammation6
- Failure of Implant1
- Tissue Damage1
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450503 ↗InjuryAug 26, 2026Loss of Osseointegration
loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450464 ↗MalfunctionMay 26, 2026Failure to Osseointegrate
MalfunctionMay 26, 2026Failure to Osseointegrate
MalfunctionMay 26, 2026Failure to Osseointegrate
MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203142 ↗MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203031 ↗MalfunctionApr 16, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903544 ↗MalfunctionMar 17, 2026Failure to Osseointegrate
MalfunctionJan 22, 2026Failure to Osseointegrate
MalfunctionAug 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRAION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872930 ↗MalfunctionAug 22, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631785 ↗MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631773 ↗MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE INSUFFICIENT BONE QUALITY.
Patient problems: Inflammation
MAUDE report 21616418 ↗InjuryNov 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
MARGINAL BONE LOSS, INDICATING PERI-IMPLANTITIS, LARGE CROWN, BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 19960354 ↗InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJul 10, 2024Failure 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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