Z5c Z5c-40-08Recalls & reported problems
Z-Systems AG · Two-piece root-form dental implant made of Zirconia Familiy Z5c Size Z5c-40-08 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5c two-piece zirconia dental implant is a root-form screw placed in the jaw. The 75 reports mostly describe the implant failing to fuse with the bone or later losing that bond, with one mentioning a fractured abutment and tissue injury or damage around the site. All 75 reports involved injuries and none reported a death. 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
- 75
- Deaths reported
- 0
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 07640166760405), received between Aug 31, 2020 and Sep 30, 2026 — classified as 75 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (54 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 Osseointegrate54
- Loss of Osseointegration20
- Fracture1
Patient problems
- Unspecified Tissue Injury67
- Tissue Damage7
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943200 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO TRAUMA/ACCIDENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 20254835 ↗InjuryAug 28, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 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, 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
InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 29, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 17, 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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