IMP. EPIKUT PLUS MT16° Ø4,5X8,5MMRecalls & reported problems across all models
Sin Sistema de Implante Nacional S/A · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM by Sin Sistema de Implante Nacional S/A in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
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
IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM 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, 2025Class IIOpen, 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 · names 2 of these models · Recall details · FDA record ↗
IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM ILM 4585NImplant, Endosseous, Root-Form1 recall0 reports
- IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM ILM 4585NImplant, Endosseous, Root-Form1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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