Z5m Z5m-50-08Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-50-08 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m zirconia dental implant is a root-form implant used as a tooth replacement. The 59 reports mostly describe the implant failing to bond with the surrounding bone, or losing that bond after surgery, often alongside tissue damage and inflammation; some mention infection or heavy teeth grinding. There are 53 injuries and no deaths. No recalls name this device, and reports have fallen from 6 to 2 in the past 12 months.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07640166760061), received between Aug 31, 2020 and Apr 16, 2026 — classified as 53 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (40 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 Osseointegrate40
- Loss of Osseointegration19
Patient problems
- Unspecified Tissue Injury45
- Tissue Damage8
- Inflammation4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895921 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826967 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionApr 30, 2025Loss of Osseointegration; Loss of Osseointegration
EARLY LOSS OF OSSEOINTEGRATION POSSIBLY DUE TO INFECTION.
Patient problems: Inflammation
MAUDE report 21932505 ↗MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE INSUFFICIENT BONE QUALITY.
Patient problems: Inflammation
MAUDE report 21631781 ↗MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: Unspecified Tissue Injury
MAUDE report 20662684 ↗InjuryNov 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 24, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO TRAUMA/ACCIDENT
Patient problems: Unspecified Tissue Injury
MAUDE report 20520100 ↗InjuryAug 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
EARLY MARGINAL BONE LOSS. (POTENTIAL PERI-IMPLANTITIS)
Patient problems: Unspecified Tissue Injury
MAUDE report 20006804 ↗InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJul 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 22, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 20, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 17, 2023Loss of Osseointegration; Loss of Osseointegration
FAILURE OF IMPLANTOLOGIST: INCORRECT PREPARATION.
Patient problems: Unspecified Tissue Injury
MAUDE report 17332993 ↗InjuryJul 17, 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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