Z5m Z5m-36-12Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-12 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m dental implant is a zirconia root-form implant. Reports mostly describe the implant failing to fuse with the jawbone, sometimes with tissue damage. There are 26 reports that name its identifier, including 23 injuries and no deaths. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07640166760139), received between Aug 31, 2020 and Oct 15, 2025 — classified as 23 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (17 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate17
- Loss of Osseointegration9
Patient problems
- Unspecified Tissue Injury17
- Tissue Damage6
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278208 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278160 ↗MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631772 ↗InjuryFeb 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 21433281 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 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 16288908 ↗InjuryDec 19, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 24, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryAug 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 22, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 9, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 9, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 9, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 9, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 9, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryOct 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 31, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 31, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 31, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 31, 2020Failure 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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