Recall Z-2177-2024 ยท ELC Scaler, Ultrasonic
Dental EZ Group Star Dental Division
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.
| Date | Jun 24, 2024 (initiated May 30, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| Action | DentalEZ Inc., StarDental Division issued Medical Device Recall Letter on 5/30/24 via Certified Mail to End-Users and Distributors. Letter states reason for recall, health risk and action to take: DentalEZ Inc., StarDental Divison requests that you immediately cease use/ distribution of the above referenced lot and return any that you have under your control to DentalEZ Inc, StarDental Division, 1816 Colonial Village Lane, Lancaster, PA 17601-5864 using the enclosed UPS RS label. Upon receipt, we will replace the Perio tip in the package and return it to you at no cost. We also request that yo |
| Quantity | 32 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881253 | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW Dentalez Group, Apr 21, 1988 |