Z5-BL Z5-BL-5010Recalls & reported problems
Z-Systems AG · Implant + TP-SNS + BL-HC · Class 2 · Implant
All models of Z5-BL (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5-BL is a dental implant used with a healing cap and cover screw. The reports mostly describe implants that fail to fuse with the surrounding bone, sometimes breaking, along with tissue injury and inflammation at the site. There are 49 reports, no deaths, 14 injuries and 35 malfunctions, and no recalls name this device. Reports of bone integration failure have risen in the past 12 months (27) compared with the previous 12 months (10).
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
- 52
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 07640166760849), received between May 21, 2024 and Sep 30, 2026 — classified as 17 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (27 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration27
- Failure to Osseointegrate23
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Unspecified Tissue Injury13
- Inflammation8
- Implant Pain2
- Bruxism1
- Inadequate Osseointegration1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943232 ↗InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943230 ↗InjurySep 30, 2026Loss of Osseointegration
InjuryAug 26, 2026Loss of Osseointegration
MalfunctionJun 25, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618801 ↗MalfunctionMay 26, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277823 ↗MalfunctionMay 18, 2026Loss of Osseointegration
MalfunctionMay 18, 2026Loss of Osseointegration
MalfunctionApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903543 ↗MalfunctionApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895932 ↗MalfunctionMar 30, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24719781 ↗MalfunctionMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706551 ↗MalfunctionMar 26, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702094 ↗MalfunctionMar 25, 2026Loss of Osseointegration
MalfunctionJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159164 ↗MalfunctionJan 23, 2026Loss of Osseointegration
MalfunctionJan 23, 2026Fracture
FRACTURE: BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159133 ↗MalfunctionJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159130 ↗MalfunctionJan 23, 2026Loss of Osseointegration
NON OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159111 ↗MalfunctionJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159109 ↗MalfunctionJan 23, 2026Loss of Osseointegration
NON OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159098 ↗MalfunctionJan 23, 2026Loss of Osseointegration
NON OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159096 ↗MalfunctionJan 23, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159095 ↗MalfunctionJan 22, 2026Failure to Osseointegrate
MalfunctionDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827187 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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