Z5m Z5m-40-10Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-40-10 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems zirconia dental implant has 131 reports, most describing the implant failing to bond with the jawbone or losing that bond. The reports mention 117 injuries and no deaths, and 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
- 131
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 07640166760030), received between Aug 31, 2020 and Aug 26, 2026 — classified as 117 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (106 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 Osseointegrate106
- Loss of Osseointegration25
Patient problems
- Unspecified Tissue Injury106
- Inflammation8
- Tissue Damage7
- No Clinical Signs, Symptoms or Conditions6
- Implant Pain3
- Inadequate Osseointegration1
Recent adverse event reports
The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450513 ↗InjuryAug 26, 2026Loss of Osseointegration
loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450507 ↗InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450496 ↗InjuryAug 26, 2026Failure to Osseointegrate
MalfunctionJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION POTENTIALLY DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Inflammation
MAUDE report 25608900 ↗MalfunctionApr 16, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903542 ↗MalfunctionApr 16, 2026Failure to Osseointegrate
MalfunctionMar 17, 2026Loss of Osseointegration
MalfunctionFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Inadequate Osseointegration
MAUDE report 24387377 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionNov 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23642247 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277983 ↗MalfunctionJul 21, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionJul 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: Implant Pain
MAUDE report 21631762 ↗MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION DUE TO INFECTION
Patient problems: Unspecified Tissue Injury
MAUDE report 20596713 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 19, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 13, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BRUXISM.
Patient problems: Unspecified Tissue Injury
MAUDE report 19960492 ↗InjuryAug 12, 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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