Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
FDA device recall Z-0920-2025 · posted 2025-01-15 · Open, Classified
Recall details
- Recalling firm
- SIN SISTEMA DE IMPLANTE NACIONAL S.A
- Reason for recall
- 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.
- Action taken
- On 9/1/2024, "URGENT: MEDICAL DEVICE RECALL" notices were emailed to customers and distributors who were told the following: The product should not be used. It does not pose a handling risk and should be separated and discarded. Complete and return the Medical Device Recall Return Response Acknowledgement and Receipt Form via email to: brian@sindentalusa.com. Customer with questions may contact the company via telephone at 0800-770-8290 between the hours of 9 and 19 (Brasilia time) or email the firm at anna.lopes@sinimplantsystem.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DZE
- Quantity affected
- 123 (US 98, OUS 25)
- Distribution
- US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
- Date initiated
- 2024-09-01
- Date posted
- 2025-01-15
- Location
- Sao Paulo, Brazil
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S.I.N. Dental Implant System (K222231) | S.I.N. - Sistema DE Implante Nacional S.A. | 2022-10-27 |