Z5m(t) Z5m(t)-40-08Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-40-08 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m(t)-40-08 is a zirconia root-form dental implant placed in the jaw bone. The 35 reports mostly describe the implant failing to bond with the surrounding bone, sometimes after heavy chewing forces, along with a couple of fractures and damage to surrounding tissue. Reports mention 32 injuries and no deaths. No recalls name this device, and reports have dropped from 4 in the earlier 12 months to 1 in the most recent.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07640166760504), received between Aug 31, 2020 and Feb 19, 2026 — classified as 32 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (19 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 Osseointegrate19
- Loss of Osseointegration15
- Fracture2
Patient problems
- Unspecified Tissue Injury28
- Tissue Damage4
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Fracture
MalfunctionAug 22, 2025Fracture; Fracture
MalfunctionAug 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRAION DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872922 ↗InjuryNov 27, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJul 10, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
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, 2023Failure to Osseointegrate; Failure to Osseointegrate
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, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 14, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 9, 2022Failure 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.
How reports and recalls are matched · Editorial policy · Report an error on this page