Z5-TL Z5-TL-5008Recalls & 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 AG Z5-TL root-form dental implant, used with a healing cap and cover screw, has 32 adverse event reports. Most describe the implant failing to bond with the surrounding bone or later losing that bond, along with tissue injury, inflammation and occasional pain. There are no deaths, 18 injuries and 14 malfunctions, and 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
- 32
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07640166768944), received between May 21, 2024 and Jun 25, 2026 — classified as 18 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (21 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 Osseointegrate21
- Loss of Osseointegration11
Patient problems
- Unspecified Tissue Injury18
- No Clinical Signs, Symptoms or Conditions8
- Inflammation3
- Bruxism1
- Implant Pain1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Loss of Osseointegration
MalfunctionMar 17, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615985 ↗MalfunctionMar 17, 2026Failure to Osseointegrate
MalfunctionFeb 19, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387378 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827011 ↗MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827008 ↗MalfunctionOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061031 ↗MalfunctionMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061017 ↗MalfunctionApr 30, 2025Loss of Osseointegration; Loss of Osseointegration
EARLY LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932499 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
INFECTION AFTER SINUS LIFT PROCEDURE, LEADING TO NON OSSEOINTEGRATION OF THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932497 ↗MalfunctionMar 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 28, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
POSSIBLE BIOMECHANICAL OVERLOAD DUE TO BRUXISM.
Patient problems: Unspecified Tissue Injury
MAUDE report 20065131 ↗InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 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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