Z5c Z5c-40-10Recalls & reported problems
Z-Systems AG · Two-piece root-form dental implant made of Zirconia Familiy Z5c Size Z5c-40-10 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5c dental implant is a two-piece zirconia root-form implant placed into bone. Most of the 125 reports describe the implant failing to bond with the bone or losing that bond, and many describe tissue injury around the implant. The reports include no deaths and 123 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
- 125
- Deaths reported
- 0
- Injuries reported
- 123
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 07640166760412), received between Aug 31, 2020 and Jun 24, 2026 — classified as 123 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (94 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 Osseointegrate94
- Loss of Osseointegration31
Patient problems
- Unspecified Tissue Injury110
- Tissue Damage13
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608902 ↗MalfunctionJan 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION POTENTIALLY DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Implant Pain
MAUDE report 24148876 ↗InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE IMPLANT WAS PLACED TOO GINGIVALLY, SO THAT THE TRANSGINGIVAL NECK OF THE IMPLANT WAS ALL EXPOSED TO THE ORAL ENVIRONMENT INSTEAD OF BEING PLACED IN THE TRANSGENGIVAL AREA. ADDITIONALLY, EXTENSIVE MARGINAL BONE LOSS IS VISIBLE IN THE X-RAY PROVIDED
Patient problems: Unspecified Tissue Injury
MAUDE report 20065400 ↗InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BRUXISM.
Patient problems: Unspecified Tissue Injury
MAUDE report 20065126 ↗InjuryAug 21, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
THE SINUS FLOOR ELEVATION AND BONE GRAFTING WERE NOT COMPLETED AROUND THE BODY AND APEX OF THE IMPLANT INSTALLED AT THE REGION OF THE TOOTH 15. IT IS VERY LIKELY THAT A PARTIAL OSSEOINTEGRATION OCCURRED, LEADING TO THE EARLY FAILURE OF THE IMPLANT.
Patient problems: Unspecified Tissue Injury
MAUDE report 19960461 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: Unspecified Tissue Injury
MAUDE report 19360262 ↗InjuryMay 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 17, 2023Loss of Osseointegration; Loss of Osseointegration
INSUFFICIENT BONE SUPPLY/ BONE QUANTITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 17333004 ↗InjuryJul 17, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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