Z5-BLRecalls & reported problems across all models
Z-Systems AG · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 405
- Deaths reported
- 0
- Injuries reported
- 182
- Recalls
- 0
We found 9 models of Z5-BL by Z-Systems AG in the FDA's device registry (GUDID). Together they are named in 405 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2021 and Sep 30, 2026 — classified as 182 injuries, 223 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (259 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-BL problems
Device problems
- Failure to Osseointegrate259
- Loss of Osseointegration124
- Fracture21
- Device Handling Problem1
Patient problems
- Unspecified Tissue Injury158
- No Clinical Signs, Symptoms or Conditions156
- Inflammation61
- Implant Pain15
- Unspecified Infection12
- Bruxism2
- Inadequate Osseointegration1
Z5-BL models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Z5-BL Z5-BL-4010Implant, Endosseous, Root-Form125 reports
- Z5-BL Z5-BL-4008Implant, Endosseous, Root-Form69 reports
- Z5-BL Z5-BL-4012Implant, Endosseous, Root-Form54 reports
- Z5-BL Z5-BL-5010Implant, Endosseous, Root-Form52 reports
- Z5-BL Z5-BL-3610Implant, Endosseous, Root-Form31 reports
- Z5-BL Z5-BL-5008Implant, Endosseous, Root-Form24 reports
- Z5-BL Z5-BL-3612Implant, Endosseous, Root-Form23 reports
- Z5-BL Z5-BL-5012Implant, Endosseous, Root-Form19 reports
- Z5-BL Z5-BL-3608Implant, Endosseous, Root-Form8 reports
Recent Z5-BL adverse event reports
The 15 most recent reports across all models, 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, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943228 ↗InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943225 ↗InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943221 ↗InjurySep 30, 2026Loss of Osseointegration
loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943216 ↗InjurySep 30, 2026Loss of Osseointegration
loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943214 ↗InjurySep 30, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943213 ↗InjurySep 30, 2026Fracture
InjurySep 30, 2026Loss of Osseointegration
InjurySep 30, 2026Fracture
Fracture: biomechanical overload.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943207 ↗InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450521 ↗InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450519 ↗InjuryAug 26, 2026Failure to Osseointegrate
Non-osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450516 ↗InjuryAug 26, 2026Failure to Osseointegrate
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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