Z5-TL Z5-TL-4012Recalls & 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
- 10
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640166768937), received between May 21, 2024 and Aug 26, 2026 — classified as 7 injuries, 3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate6
- Loss of Osseointegration3
- Break1
Patient problems
- Unspecified Tissue Injury6
- Inflammation2
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Loss of Osseointegration
MalfunctionDec 17, 2025Break; Break
MalfunctionJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION SUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Failure of Implant
MAUDE report 22343594 ↗InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 21283276 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2024Loss of Osseointegration; Loss of Osseointegration
NON OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 20254828 ↗InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
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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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