Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall S.I.N. Dental Implant System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall S.I.N. Dental Implant Systemsee related information
Date Initiated by FirmSeptember 01, 2024
Date PostedJanuary 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0920-2025
Recall Event ID 95983
510(K)NumberK222231 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductImplant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Code Information UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01
Recalling Firm/
Manufacturer		 SIN SISTEMA DE IMPLANTE NACIONAL S.A
Jardim Analia Franco
Rua Soldador Ocimar Guimaraes da Silva 421
Sao Paulo Brazil
For Additional Information Contact
55 11 66941070
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 in Commerce123 (US 98, OUS 25)
DistributionUS distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DZE
-
-