Z5-TL Z5-TL-4008Recalls & 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 is placed in the jaw to support dental work. The 25 reports mostly describe the implant not bonding with the bone or losing that bond, with some mentioning tissue injury and inflammation. The reports mention no deaths and 9 injuries. 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
- 27
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07640166768913), received between May 21, 2024 and Sep 30, 2026 — classified as 11 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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 Osseointegrate18
- Loss of Osseointegration9
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Unspecified Tissue Injury8
- Inflammation4
- Bruxism1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943233 ↗InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943219 ↗InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450485 ↗MalfunctionApr 16, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903530 ↗MalfunctionMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702093 ↗MalfunctionMar 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615980 ↗MalfunctionFeb 19, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387430 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827035 ↗MalfunctionDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827033 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827010 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826990 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826986 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826968 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionOct 15, 2025Failure to Osseointegrate; Failure 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 23301316 ↗MalfunctionJun 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Bruxism
MAUDE report 22343597 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932498 ↗InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 28, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 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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