CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
FDA device recall Z-0285-2024 · posted 2023-11-09 · Open, Classified
Recall details
- Recalling firm
- Young Dental Manufacturing I, LLC
- Reason for recall
- one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Open, Classified
- Product code
- EGS
- Quantity affected
- 12 units
- Distribution
- US: IN, TN, MO
- Date initiated
- 2023-10-06
- Date posted
- 2023-11-09
- Location
- Earth City, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROPHYLAXIS ANGLE (K780752) | Young Dental Manufacturing Co. 1, LLC | 1978-05-26 |