Z5-BL Z5-BL-4008Recalls & 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 endosseous dental implant, used with an abutment and healing cap, is a root-form implant placed in the jaw. The 69 reports mostly describe the implant failing to bond with the surrounding bone, or losing that bond later, along with tissue injury and inflammation at the site; 47 reports involve injuries and none report 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
- 69
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 07640166760801), received between Mar 9, 2022 and Aug 26, 2026 — classified as 47 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (46 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 Osseointegrate46
- Loss of Osseointegration22
- Fracture1
Patient problems
- Unspecified Tissue Injury44
- No Clinical Signs, Symptoms or Conditions17
- Inflammation5
- Unspecified Infection2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450519 ↗InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450516 ↗InjuryAug 26, 2026Failure to Osseointegrate
MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203154 ↗MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203034 ↗MalfunctionApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895922 ↗MalfunctionMar 23, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24665058 ↗MalfunctionMar 17, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615981 ↗MalfunctionJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159148 ↗MalfunctionJan 22, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148833 ↗MalfunctionJan 22, 2026Failure to Osseointegrate
NON OSSEOINTEGRATION RELATED TO INFLAMMATION/INFECTION.
Patient problems: Inflammation
MAUDE report 24148758 ↗MalfunctionJan 22, 2026Failure to Osseointegrate
MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23827091 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827012 ↗MalfunctionOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionOct 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: Inflammation
MAUDE report 23423625 ↗MalfunctionOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION, IMMEDIATE IMPLANT PLACEMENT IN AN AREA OF REDUCED BONE QUANTITY.
Patient problems: Implant Pain
MAUDE report 22893769 ↗MalfunctionAug 26, 2025Fracture; Fracture
FRACTURE: BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893721 ↗MalfunctionAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893680 ↗MalfunctionAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893673 ↗MalfunctionJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22139418 ↗MalfunctionMay 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061029 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932513 ↗MalfunctionApr 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21855806 ↗
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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