UnititeRecalls & reported problems across all models
Sin Sistema de Implante Nacional S/A · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Unitite model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 3 models of Unitite by Sin Sistema de Implante Nacional S/A in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between May 26, 2026 and Jun 9, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Unitite recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 30, 2025Open, Classified
Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.
Z-0017-2026 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported Unitite problems
Device problems
- Failure to Osseointegrate2
Patient problems
- Insufficient Information2
Unitite models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Unitite UCMC 6007NImplant, Endosseous, Root-Form1 recall0 reports
- Unitite UCM 4310NImplant, Endosseous, Root-Form1 report
- Unitite UCMC 4005NImplant, Endosseous, Root-Form1 report
Recent Unitite adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
Other Sin Sistema de Implante Nacional S/A products
All Sin Sistema de Implante Nacional S/A 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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