Dental Scaler Tip May Not Seat Properly, Posing Injury Risk
Dental EZ Group is recalling certain Titan Scaler Tip (Perio, Model 261669) units due to an oversized tip holder condition that may prevent proper seating, creating a risk of injury during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a mechanical defect that may prevent proper seating of a medical device during use. No injuries or illnesses have been reported; the risk is theoretical but involves an instrument used in oral procedures, warranting a High severity rating.
Plain-English summary
Dental EZ Group Star Dental Division is recalling Titan Scaler Tip - Perio (Model/Catalog Number 261669) units. The scaler tip is designed to be used with an air drive scaler for subgingival scaling and fine access, specifically for lingual supragingival scaling of mandibular incisors and deep local pockets.
The recalled units have an oversized condition in the tip holder portion of the scaler tip assembly. This oversized condition may prevent the scaler tip from staying properly seated in the holder during use, which may cause injury to the user or patient.
The affected units were distributed nationwide in the United States. The recalled lot number is 4881439 with date code P424. Affected units can be identified by Model/Catalog Number 261669 and UDI-DI D702261669.
Consumers and dental professionals should stop using the recalled scaler tips immediately. Contact Dental EZ Group Star Dental Division for instructions on returning the product or obtaining a replacement.
The recalled product
- 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.
- Manufacturer
- Dental EZ Group Star Dental Division
- Hazard
- improper-seating
- defective-assembly
- injury-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI D702261669 Lot Number 4881439 Date code stamp P424
Distribution
Distributed nationwide across the United States.
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