Z5-BL Z5-BL-3608Recalls & reported problems
Z-Systems AG · Implant + TP-SNS + BL-HC · Class 2 · Implant
All models of Z5-BL (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640166768463), received between Aug 13, 2024 and Sep 30, 2026 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate6
- Fracture1
- Loss of Osseointegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Implant Pain2
- Unspecified Tissue Injury1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Fracture: biomechanical overload.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943207 ↗MalfunctionMay 18, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203122 ↗MalfunctionMar 26, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706557 ↗MalfunctionJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22139416 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932514 ↗MalfunctionApr 17, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
FRACTURE DUE TO INCORRECT POSITION
Patient problems: Unspecified Tissue Injury
MAUDE report 19971084 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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