Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival sc

FDA device recall Z-2177-2024 · posted 2024-06-24 · Open, Classified

Recall details

Recalling firm

Dental EZ Group Star Dental Division

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

ELC

Quantity affected

32 units

Distribution

US Nationwide distribution.

Date initiated

2024-05-30

Date posted

2024-06-24

Location

Lancaster, PA

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