Z5-TLRecalls & reported problems across all models
Z-Systems AG · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 162
- Deaths reported
- 0
- Injuries reported
- 83
- Recalls
- 0
We found 6 models of Z5-TL by Z-Systems AG in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between May 21, 2024 and Sep 30, 2026 — classified as 83 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (117 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Z5-TL problems
Device problems
- Failure to Osseointegrate117
- Loss of Osseointegration44
- Break1
Patient problems
- Unspecified Tissue Injury77
- No Clinical Signs, Symptoms or Conditions47
- Inflammation22
- Implant Pain7
- Unspecified Infection4
- Bruxism2
- Failure of Implant2
- Insufficient Information1
Z5-TL models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Z5-TL Z5-TL-4010Implant, Endosseous, Root-Form44 reports
- Z5-TL Z5-TL-5010Implant, Endosseous, Root-Form41 reports
- Z5-TL Z5-TL-5008Implant, Endosseous, Root-Form32 reports
- Z5-TL Z5-TL-4008Implant, Endosseous, Root-Form27 reports
- Z5-TL Z5-TL-4012Implant, Endosseous, Root-Form10 reports
- Z5-TL Z5-TL-5012Implant, Endosseous, Root-Form8 reports
Recent Z5-TL adverse event reports
The 15 most recent reports across all models, 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, 2026Loss of Osseointegration
loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943231 ↗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 50450502 ↗InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450485 ↗InjuryAug 26, 2026Loss of Osseointegration
MalfunctionJun 25, 2026Loss of Osseointegration
MalfunctionJun 24, 2026Failure to Osseointegrate
NON OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608894 ↗MalfunctionJun 24, 2026Failure to Osseointegrate
MalfunctionJun 24, 2026Failure to Osseointegrate
MalfunctionMay 26, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276627 ↗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 ↗
Other Z-Systems AG products
All Z-Systems AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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