The Recall Desk
HighFDA (Devices)·Z-0017-2026·Announced 2025-10-08

Dental Implants Recalled Due to Improper Storage Conditions

S.I.N. Implant System dental implants were imported under improper temperature and storage conditions that may have damaged packaging and compromised product quality. Affected implants were distributed nationwide.

What this means for you

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: FDA Class II recall of a risk-of-harm medical device where improper storage conditions may have compromised packaging integrity and product performance. No illnesses or injuries have been reported, but packaging compromise of dental implants presents potential for product failure during clinical use, warranting High severity.

Plain-English summary

S.I.N. Implant System Ltda is recalling multiple models of IMPLANT EPIKUT PLUS MT16 and related dental implants. The implants were imported under temperature and storage conditions that do not comply with instructions for use and product labeling, which may have caused packaging damage.

Packaging damage could compromise the product quality and performance of the dental implants. These implants are used by dental practitioners for oral surgical procedures and rely on proper packaging to maintain sterility and structural integrity.

Approximately 4,367 units were distributed nationwide. Dental practitioners who have received these implants should contact S.I.N. Implant System Ltda for guidance on affected lot numbers and replacement options. Consumers who have received these implants should consult their dentist regarding any concerns.

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; IMPLANT
Manufacturer
S.I.N. Implant System Ltda
Category
Medical Device — Dental Implants
Hazard
  • packaging-damage
  • compromised-sterility

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.

Related recalls

Same category