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 CONTRA GRAY

  • 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 CONTRA GRAYsee related information
Date Initiated by FirmOctober 06, 2023
Date PostedNovember 09, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0285-2024
Recall Event ID 93176
510(K)NumberK780752 
Product Classification Handpiece, contra- and right-angle attachment, dental - Product Code EGS
ProductCONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Code Information UDI/DI 10302731631127, Lot Number 223466
FEI Number 1941138
Recalling Firm/
Manufacturer		 Young Dental Manufacturing I, LLC
13705 Shoreline Ct E
Earth City MO 63045-1202
For Additional Information ContactJose Espino
224-622-7191
Manufacturer Reason
for Recall		one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
FDA Determined
Cause 2		Packaging process control
ActionYoung Dental Manufacturing CO 1, LLC issued a MEDICAL DEVICE RECALL notice to its consignees on 10/06/2023 by USPS certified mail with return receipt notification. The notice explained the issue and requested that the product be returned or destroyed. Distributors were directed to notify their customers. Replacement product will be provided directly from the recalling firm; refunds will be handled through the distributor and credit issued.
Quantity in Commerce12 units
DistributionUS: IN, TN, MO
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 = EGS
-
-