SIN SISTEMA DE IMPLANTE NACIONAL S.A recalls Implant Epikut S Plus CM 16-Degrees 4

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0920-2025
• FDA 510(k) clearance · K222231The device's official FDA premarket clearance record
• FDA device classification · DZEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3640The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SIN SISTEMA DE IMPLANTE NACIONAL S.ASearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.