Z5m Z5m-40-12Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-40-12 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m root-form dental implant is a small zirconia screw placed into the jaw to hold a replacement tooth. The 43 reports mostly describe the implant failing to bond with the surrounding bone, sometimes after infection, along with tissue irritation and pain; one report describes the implant fracturing after a blow. There were no deaths and 38 injuries. 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
- 43
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 07640166760146), received between Sep 10, 2020 and May 26, 2026 — classified as 38 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (37 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 Osseointegrate37
- Loss of Osseointegration5
- Fracture1
Patient problems
- Unspecified Tissue Injury36
- Inflammation3
- Tissue Damage2
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Failure to Osseointegrate
MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionJul 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionApr 17, 2025Fracture; Fracture
MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631769 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
POOR BONE QUALITY AND ADJACENT TEETH WITH DEFICIENT RESTORATION (POSSIBLY INFECTED). POSSIBLE BIOMECHANICAL OVERLOAD DUE TO FREE END CROWN IN THE POSTERIOR REGION.
Patient problems: Unspecified Tissue Injury
MAUDE report 20065120 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO PERIIMPLANTITIS.
Patient problems: Unspecified Tissue Injury
MAUDE report 19360235 ↗InjuryJul 27, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 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, 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, 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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