Recall Z-0920-2025 ยท DZE Implant, Endosseous, Root-Form
SIN SISTEMA DE IMPLANTE NACIONAL S.A
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
| Date | Jan 15, 2025 (initiated Sep 1, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222231 | S.I.N. Dental Implant System S.I.N. - Sistema DE Implante Nacional S.A., Oct 27, 2022 |