Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
This recall is currently active, issued January 15, 2025. It was issued by Sin Sistema De Implante Nacional S.A Jardim Analia Franco Rua Soldador Ocimar Guimaraes Da Silva.
- Company
- Sin Sistema De Implante Nacional S.A Jardim Analia Franco Rua Soldador Ocimar Guimaraes Da Silva
- Recall Initiated
- September 1, 2024
- Posted
- January 15, 2025
- Recall Number
- Z-0920-2025
- Quantity
- 123 (US 98, OUS 25)
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Lot / Code Info
UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
Root Cause
Process control
Action Taken
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.