FDA Medical Device Recalls (openFDA)
Dental EZ Group Star Dental Division: Titan Scaler Tip - Perio Model/Catalog Number: 261669 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.
- Recall number
- Z-2177-2024
- Recalling firm
- Dental EZ Group Star Dental Division
- Product
- Titan Scaler Tip - Perio Model/Catalog Number: 261669 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.
- Status
- Open, Classified
- Initiated
- 2024-05-30
- Posted
- 2024-06-24
- Terminated
- not on file
- Reason
- 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
- Root cause
- 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
- 32 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI D702261669 Lot Number 4881439 Date code stamp P424
- 510(k) numbers
- ["K881253"]
- PMA numbers
- not on file
- Product code
- ELC
- Firm FEI
- 2520265
- Firm city
- Lancaster
- Firm state
- PA
- Firm country
- not on file
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