The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0017-2026·Announced 2025-10-08

Dental implants recalled after import under non compliant temperature and storage conditions

S.I.N. Implant System is recalling 4,367 Epikut Plus dental implants imported under temperature and storage conditions that do not comply with the instructions for use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: possible packaging damage on an implanted device could compromise quality and performance, and no injuries are reported.

Plain-English summary

Epikut Plus MT16 dental implants and related implant references, in diameters from 3.5mm to 4.5mm and lengths from 8.5mm to 20.0mm, are being recalled. The affected references include ILM 3510N, ILM 3511N, ILM 3513N, ILM 3515N, ILM 3810N, ILM 3811N, ILM 3815N, ILM 4010N, ILM 4011N, ILM 4013N, ILM 4020N, ILM 4085N, ILM 4513N and ILM 4515N.

The 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.

The recall covers 4,367 units, distributed nationwide in the United States including in Texas, Illinois, Kentucky, North Carolina, Tennessee, Colorado, California, Missouri, Maryland, Alabama, Florida, Pennsylvania, Utah, Nebraska, Idaho, Arizona, Washington, Oklahoma, Oregon, Nevada, New Jersey, Virginia, New York, Louisiana, Connecticut, South Dakota, South Carolina, Hawaii, Kansas, Massachusetts, Michigan, New Mexico, Ohio, Montana, Wisconsin, Minnesota and Maine. The FDA has classified the action as Class II.

Dental practices should identify affected reference and lot numbers and follow the firm's instructions rather than placing implants from the listed lots.

The recalled product

Product
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…
Manufacturer
S.I.N. Implant System Ltda
Category
Medical Device — Dental implant
Hazard
Affected units
6,360

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF/UDI-DI/Lot(Expiration): ILM 3510N/7899995277558/X010469795(9/12/2026)
  • ILM 3511N/7899995274342/X020477141(7/11/2027)
  • X040490928(1/3/2028)
  • X030483330(1/2/2028)
  • X030482747(9/2/2027)
  • X030482813(10/10/2027)
  • W100457486(2/9/2027)
  • X030482750(9/2/2027)
  • W020415041(10/12/2026)
  • X020477137(3/4/2027)
  • ILM 3513N/7899995274335/W080447571(2/4/2028)
  • X010469706(3/4/2028)
  • X010471894(4/11/2028)
  • W020415045(1/3/2028)
  • X120531584(6/5/2028)
  • X040490953(5/11/2028)
  • Y010537386(6/12/2028)
  • ILM 3515N/7899995280893/W020420816(6/12/2028)
  • X030484303(10/2/2028)
  • X010472646(9/12/2028)

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

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