Z5m(t) Z5m(t)-40-12Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-40-12 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Z-Systems AG Z5m(t)-40-12 zirconia root-form dental implant, a small screw-like post placed into the jawbone to hold a replacement tooth. The 70 reports mostly describe implants that fail to fuse with the surrounding bone, or that lose that fusion after surgery, along with tissue injury and damage at the implant site. There are 66 injuries and no deaths mentioned. 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
- 70
- Deaths reported
- 0
- Injuries reported
- 66
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 07640166760528), received between Aug 31, 2020 and Apr 16, 2026 — classified as 66 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (43 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 Osseointegrate43
- Loss of Osseointegration27
Patient problems
- Unspecified Tissue Injury56
- Tissue Damage10
- No Clinical Signs, Symptoms or Conditions3
- Inflammation1
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895915 ↗MalfunctionApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895914 ↗MalfunctionOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionJul 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22552976 ↗InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 27, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 20794713 ↗InjurySep 19, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: Unspecified Tissue Injury
MAUDE report 20254806 ↗InjuryAug 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 19360308 ↗InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 19360301 ↗InjuryJan 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2023Loss of Osseointegration; Loss of Osseointegration
FRACTURE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 17342318 ↗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 16288880 ↗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, 2023Failure 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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