Epikut S Plus CM Implant (SIN) – Diameter Labeling Error (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Brand
SIN SISTEMA DE IMPLANTE NACIONAL S.A Jardim Analia Franco Rua Soldador Ocimar Guimaraes da Silva
Lot Codes / Batch Numbers
UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
Products Sold
UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
SIN SISTEMA DE IMPLANTE NACIONAL S.A Jardim Analia Franco Rua Soldador Ocimar Guimaraes da Silva is recalling Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N due to 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 den. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, ID, IL, KY, NJ, NY, OH, TX
Page updated: Jan 10, 2026