Z-2177-2024 Class II Ongoing
FDA device recall Z-2177-2024 was initiated by Dental EZ Group Star Dental Division on May 30, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2024
- Initiation Date
- May 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
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.
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 Pattern
US Nationwide distribution.
Code Information
UDI-DI D702261669 Lot Number 4881439 Date code stamp P424