Z5m lblcRecalls & reported problems across all models
Z Systems USA Incorporated · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 8 models of Z5m lblc by Z Systems USA Incorporated in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2021 and Oct 15, 2025 — classified as 21 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (19 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 Z5m lblc problems
Device problems
- Failure to Osseointegrate19
- Loss of Osseointegration3
Patient problems
- Unspecified Tissue Injury21
- Implant Pain1
Z5m lblc models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Z5m lblc Z5m-40-10lc-25Implant, Endosseous, Root-Form9 reports
- Z5m lblc Z5m-36-10lbImplant, Endosseous, Root-Form4 reports
- Z5m lblc Z5m-40-10lbImplant, Endosseous, Root-Form3 reports
- Z5m lblc Z5m-36-10lc-25Implant, Endosseous, Root-Form2 reports
- Z5m lblc Z5m-36-08lbImplant, Endosseous, Root-Form1 report
- Z5m lblc Z5m-40-08lbImplant, Endosseous, Root-Form1 report
- Z5m lblc Z5m-36-08lc-25Implant, Endosseous, Root-Form1 report
- Z5m lblc Z5m-40-12lc-25Implant, Endosseous, Root-Form1 report
Recent Z5m lblc adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: Unspecified Tissue Injury
MAUDE report 19960505 ↗InjuryMay 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
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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