IMP. EPIKUT MT16° Ø3,5X15,0MM ILM 3515Recalls & reported problems
Sin Sistema de Implante Nacional S/A · IMP. EPIKUT MT16° Ø3,5X15,0MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K222231); they may or may not involve this specific model.
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.
Recalls naming this device
- 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 · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K222231. One submission often covers many models, so check the product and lot details in each record.
- Z-0920-2025 · Sep 1, 2024 · Open, ClassifiedImplant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Other Prosthesis, Nose, Internal devices
- Vistafix 93101Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL14 reports
- Vistafix 92997Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL8 reports
- Vistafix 92996Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL6 reports
- Vistafix 93100Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL6 reports
- Vistafix 92995Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL4 reports
- Vistafix 92998Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL4 reports
- Vistafix 92994Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL2 reports
- Fixture ST 4mm 90440Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL2 reports
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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