SIN SISTEMA DE IMPLANTE NACIONAL S.A Recall 95983
Description: Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
SIN SISTEMA DE IMPLANTE NACIONAL S.A Recall 95983 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0920-2025 |
| Event ID | 95983 |
| Event Description | Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N |
| Product Type | Devices |
| Distribution | US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil. |
| Quantity | 123 (US 98, OUS 25) |
| Recall Reason | Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery. |
| Device Classification | 20250122 |
| Device Code Info | UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01 |
| Center Classification Date | 20250115 |
| Recall Initiation Date | 20240901 |
| Recalling Firm | SIN SISTEMA DE IMPLANTE NACIONAL S.A |
| Initial Notification | Letter |
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