Z5m(t) Z5m(t)-40-10Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-40-10 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m(t) zirconia dental implant is a root-form screw placed into the jawbone. The 64 reports mostly describe implants that fail to fuse with the bone or lose that fusion, along with one fractured implant, often with tissue damage or pain at the site. No deaths and 56 injuries were reported. There are no recalls naming this device, and reports have dropped from 8 in the previous 12 months to 1.
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
- 64
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 07640166760511), received between Aug 31, 2020 and Dec 17, 2025 — classified as 56 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (41 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 Osseointegrate41
- Loss of Osseointegration22
- Fracture1
Patient problems
- Unspecified Tissue Injury50
- No Clinical Signs, Symptoms or Conditions6
- Tissue Damage6
- Implant Pain1
- Inflammation1
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826988 ↗MalfunctionAug 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872890 ↗MalfunctionAug 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSUFFICIENT BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872889 ↗MalfunctionJun 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22343593 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION POSSIBLY DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932524 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION POSSIBLY DUE TO BIOMECHANICAL OVERLOAD/BRUXISM.
Patient problems: Implant Pain
MAUDE report 21932518 ↗MalfunctionApr 30, 2025Fracture; Fracture
FRACTURE: INSUFFICIENT BONE SUPPORT, BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932515 ↗MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE INSUFFICIENT BONE QUALITY.
Patient problems: Inflammation
MAUDE report 21631778 ↗InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 22, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO BRUXISM.
Patient problems: Unspecified Tissue Injury
MAUDE report 19360303 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
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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