Z5c Z5c-50-12Recalls & reported problems
Z-Systems AG · Two-piece root-form dental implant made of Zirconia Familiy Z5c Size Z5c-50-12 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5c is a two-piece root-form dental implant made of zirconia, used as a replacement tooth root. The 51 reports mostly describe the implant failing to bond with the surrounding jawbone or losing that bond over time, along with tissue injury at the implant site. There are 51 injuries and no deaths, and 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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 07640166760450), received between Aug 31, 2020 and Aug 12, 2024 — classified as 51 injuries.
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 Osseointegration14
Patient problems
- Unspecified Tissue Injury45
- Tissue Damage6
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryMar 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 25, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryMay 7, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 9, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryMar 9, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryMar 9, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryNov 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
PATIENT TRAUMATIZED IMPLANT DURING OSSEOINTEGRATION PHASE.
Patient problems: Unspecified Tissue Injury
MAUDE report 12292715 ↗
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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