Z5-BL Z5-BL-5008Recalls & reported problems
Z-Systems AG · Implant + TP-SNS + BL-HC · Class 2 · Implant
All models of Z5-BL (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5-BL dental implant sits in the jaw to hold replacement teeth. Reports mostly describe implants failing to fuse to the bone or loosening after fusing, sometimes with tissue injury or infection. There are 24 reports naming its identifier, including 8 injuries and no deaths. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07640166760832), received between May 21, 2024 and Aug 26, 2026 — classified as 8 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (16 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
- Loss of Osseointegration16
- Failure to Osseointegrate7
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Unspecified Tissue Injury7
- Unspecified Infection2
- Implant Pain1
- Inflammation1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450498 ↗MalfunctionJun 25, 2026Loss of Osseointegration
MalfunctionJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608915 ↗MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203023 ↗MalfunctionJan 23, 2026Loss of Osseointegration
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159151 ↗MalfunctionJan 22, 2026Device Handling Problem
PATIENT'S GENERAL DENTIST OVERTORQUES IMPLANT WHEN PLACING ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148938 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23827092 ↗MalfunctionOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278047 ↗MalfunctionJun 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22139417 ↗MalfunctionMay 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061169 ↗MalfunctionMay 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061023 ↗MalfunctionMay 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061022 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21932516 ↗MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616424 ↗MalfunctionMar 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616421 ↗MalfunctionMar 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616419 ↗InjuryFeb 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
FRACTURE DUE BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 19960494 ↗InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 21, 2024Loss 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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