Z5-TL Z5-TL-5012Recalls & 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
- 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 07640166768968), received between Aug 12, 2024 and Mar 30, 2026 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (5 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
- Loss of Osseointegration5
- Failure to Osseointegrate3
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Unspecified Tissue Injury2
- Inflammation1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24720105 ↗MalfunctionMar 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689658 ↗MalfunctionFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387398 ↗MalfunctionFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387396 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061162 ↗InjuryNov 12, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 20662662 ↗InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
FRACTURE, DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 19960332 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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