ClearanceBrief
Recall Z-0017-2026 ยท DZE Implant, Endosseous, Root-Form

S.I.N. Implant System Ltda

IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM

DateOct 1, 2025 (initiated Jul 30, 2025)
StatusOpen, Classified
ReasonDental 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.
Root causeEnvironmental control
ActionOn 7/30/2025, correction notices were emailed to customers who were asked to do the following: 1) Return affected devices 2) Complete and return the response form via email to sbassett@sindentalusa.com 3) Disseminate the notice to staff and to other services or facilities, as applicable.
Quantity6,360
DistributionUS Nationwide distribution including in the states of TX, IL, KY, NC, TN, CO, CA, MO, MD, AL, FL, PA, UT, NE, ID, AZ, WA, OK, OR, NV, NJ, VA, NY, LA, CT, SD, SC, HI, KS, MA, MI, NM, OH, MT, WI, MN, ME.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.