Z5-TL Z5-TL-5010Recalls & reported problems
Z-Systems AG · Implant + TP-SNS + BL-HC · Class 2 · Implant
All models of Z5-TL (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5-TL dental implant has 40 adverse event reports, with no deaths and 23 injuries. The reports mostly describe the implant failing to integrate with bone, sometimes with tissue injury. 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
- 41
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07640166768951), received between May 21, 2024 and Sep 30, 2026 — classified as 24 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (32 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 Osseointegrate32
- Loss of Osseointegration9
Patient problems
- Unspecified Tissue Injury23
- No Clinical Signs, Symptoms or Conditions9
- Inflammation6
- Implant Pain2
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 41 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 50943231 ↗MalfunctionJun 24, 2026Failure to Osseointegrate
MalfunctionJun 24, 2026Failure to Osseointegrate
MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203028 ↗MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203024 ↗MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203016 ↗MalfunctionApr 16, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903549 ↗MalfunctionMar 30, 2026Failure to Osseointegrate
MalfunctionMar 23, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24665059 ↗MalfunctionMar 17, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615987 ↗MalfunctionFeb 19, 2026Failure to Osseointegrate
MalfunctionJan 22, 2026Failure to Osseointegrate
MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: Inflammation
MAUDE report 23301023 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300992 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278002 ↗MalfunctionApr 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS, EXCESS OF CEMENT AND PLAQUE ACCUMULATION COULD HAVE LED TO PERI-IMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 21932508 ↗MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 21283507 ↗InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 24, 2024Loss of Osseointegration; Loss of Osseointegration
BIOMECHANICAL OVERLOAD: AFTER DEF. PROSTHETIC RESTORATION
Patient problems: Unspecified Tissue Injury
MAUDE report 20520101 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
Other Implant, Endosseous, Root-Form devices
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- 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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