Z-2178-2024 Class II Ongoing
FDA device recall Z-2178-2024 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: 192 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
- 192 units
Product Description
Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 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 : D7022645630 (1) P/N 264563: lot # 4874201, lot # 4904771 (2) P/N 264565, lot # 4964531