FDA Medical Device Recalls (openFDA)
SIN SISTEMA DE IMPLANTE NACIONAL S.A: Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
- Recall number
- Z-0920-2025
- Recalling firm
- SIN SISTEMA DE IMPLANTE NACIONAL S.A
- Product
- Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
- Status
- Open, Classified
- Initiated
- 2024-09-01
- Posted
- 2025-01-15
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 123 (US 98, OUS 25)
- Distribution
- US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
- Lot, serial or model codes
- UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
- 510(k) numbers
- ["K222231"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3004201263
- Firm city
- Sao Paulo
- Firm state
- not on file
- Firm country
- Brazil
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28