Z5c Z5c-A00Recalls & reported problems
Z-Systems AG · abutment made of Zirconia Familiy Z5c Size Z5c-A00, straight · Class 2 · Implant
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07640166760474), received between Sep 11, 2024 and Aug 26, 2026 — classified as 10 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration9
- Fracture3
- Failure to Osseointegrate1
Patient problems
- Unspecified Tissue Injury9
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Failure to Osseointegrate
MalfunctionJan 23, 2026Fracture
ABUTMENT: FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159149 ↗MalfunctionJan 23, 2026Fracture
ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159147 ↗MalfunctionJan 22, 2026Fracture
ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148763 ↗InjuryOct 25, 2024Loss of Osseointegration; Loss of Osseointegration
FRACTURE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 20533258 ↗InjuryOct 25, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 25, 2024Loss of Osseointegration; Loss of Osseointegration
FRACTURE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 20533185 ↗InjuryOct 25, 2024Loss of Osseointegration; Loss of Osseointegration
FRACTURE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 20533091 ↗InjuryOct 24, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 24, 2024Loss of Osseointegration; Loss of Osseointegration
ABUTMENT FRACTURE: BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 20521457 ↗InjuryOct 24, 2024Loss of Osseointegration; Loss of Osseointegration
ABUTMENT FRACTURE: BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 20521455 ↗InjuryOct 24, 2024Loss of Osseointegration; Loss of Osseointegration
ABUTMENT FRACTURE: BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 20521453 ↗InjurySep 11, 2024Loss of Osseointegration; Loss of Osseointegration
Other Abutment, Implant, Dental, Endosseous devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.