Recall Z-0285-2024 ยท EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Young Dental Manufacturing I, LLC
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
| Date | Nov 9, 2023 (initiated Oct 6, 2023) |
| Status | Open, Classified |
| Reason | one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs. |
| Root cause | Packaging process control |
| Action | Young Dental Manufacturing CO 1, LLC issued a MEDICAL DEVICE RECALL notice to its consignees on 10/06/2023 by USPS certified mail with return receipt notification. The notice explained the issue and requested that the product be returned or destroyed. Distributors were directed to notify their customers. Replacement product will be provided directly from the recalling firm; refunds will be handled through the distributor and credit issued. |
| Quantity | 12 units |
| Distribution | US: IN, TN, MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780752 | PROPHYLAXIS ANGLE Young Dental Manufacturing Co. 1, LLC, May 26, 1978 |