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 Titan Scaler Tip Perio

  • 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 Titan Scaler Tip Perio see related information
Date Initiated by Firm May 30, 2024
Date Posted June 24, 2024
Recall Status1 Open3, Classified
Recall Number Z-2178-2024
Recall Event ID 94783
510(K)Number K881253  
Product Classification Scaler, ultrasonic - Product Code ELC
Product Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669)
(1) P/N 264563
(2)
P/N 264565
The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
Code Information UDI-DI : D7022645630 (1) P/N 264563: lot # 4874201, lot # 4904771 (2) P/N 264565, lot # 4964531
Recalling Firm/
Manufacturer		 Dental EZ Group Star Dental Division
1816 Colonial Village Ln
Lancaster PA 17601-5807
For Additional Information Contact NA
717-291-1161
Manufacturer Reason
for Recall		 Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
FDA Determined
Cause 2		 Process control
Action DentalEZ Inc., StarDental Division issued Medical Device Recall Letter on 5/30/24 via Certified Mail to End-Users and Distributors. Letter states reason for recall, health risk and action to take: DentalEZ Inc., StarDental Divison requests that you immediately cease use/ distribution of the above referenced lot and return any that you have under your control to DentalEZ Inc, StarDental Division, 1816 Colonial Village Lane, Lancaster, PA 17601-5864 using the enclosed UPS RS label. Upon receipt, we will replace the Perio tip in the package and return it to you at no cost. We also request that you contact your customers that have purchased any of the above referenced Blissonic Scalers from the referenced lot. Please direct your customers to go to our website at DentalEZ.com and follow the instructions below in order to have the Perio scaler tip shipped directly to StarDental at no charge. Upon receipt of the Perio tip, we will replace the tip directly to your customer at no charge. Please complete and return the enclosed form by July 1, 2024, indicating whether you have any of the effected lot of Blis-sonic Scalers and whether you are able to contact your customers regarding this recall notification as well. Any questions and concerns should be forwarded to Kay Engle at StarQuality@Dentalez.com.
Quantity in Commerce 192 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = ELC and Original Applicant = DENTALEZ GROUP
-
-