Z5-BL Z5-BL-4012Recalls & 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 dental implant is a root-form screw placed in the jaw. Most of the 54 reports describe the implant failing to bond with the surrounding bone, or losing that bond after it had formed, along with two fractures;34 reports mention injuries such as tissue damage, inflammation, pain, and one infection. No deaths were reported. There are no recalls naming 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
- 54
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07640166760825), received between Nov 11, 2021 and May 18, 2026 — classified as 34 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (42 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 Osseointegrate42
- Loss of Osseointegration10
- Fracture2
Patient problems
- Unspecified Tissue Injury34
- No Clinical Signs, Symptoms or Conditions11
- Inflammation5
- Implant Pain3
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203026 ↗MalfunctionMay 18, 2026Loss of Osseointegration
MalfunctionMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706552 ↗MalfunctionJan 22, 2026Failure to Osseointegrate
MalfunctionJan 22, 2026Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION, BIOMECHANICAL OVERLOAD.
Patient problems: Inflammation
MAUDE report 24148652 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827032 ↗MalfunctionDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826987 ↗MalfunctionNov 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23642240 ↗MalfunctionNov 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23642236 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893783 ↗MalfunctionAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893782 ↗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 22893656 ↗MalfunctionJul 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22552983 ↗MalfunctionMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061018 ↗MalfunctionMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionMar 18, 2025Fracture; Fracture
MalfunctionMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21616425 ↗InjuryFeb 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 21433299 ↗InjuryFeb 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 20662881 ↗InjuryNov 12, 2024Failure 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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