Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingiv
Summary
The FDA issued a Class II for Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is use by Dental EZ Group Star Dental Division. 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 cau.
Details
Source
Device Recall
External ID
Z-2177-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI-DI D702261669 Lot Number 4881439 Date code stamp P424
Quantity Affected: 32 units
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
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-30
Company
Lancaster, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Dental EZ Group Star Dental Division has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dental EZ Group Star Dental Division) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dental EZ Group Star Dental Division have FDA actions?
Dental EZ Group Star Dental Division has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2177-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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