Device 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.
Z-2177-2024
Product summary
- Event
- Event 94783
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-2177-2024
Official wording
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 cause injury
Code information: UDI-DI D702261669 Lot Number 4881439 Date code stamp P424
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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