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Open, Classified

CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles

FDA Recall Z-0285-2024 · Posted 2023-11-09

Recalling FirmYoung Dental Manufacturing I, LLC
Recall StatusOpen, Classified
Product CodeEGS
Date Initiated2023-10-06
Product Quantity12 units

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

US: IN, TN, MO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K780752PROPHYLAXIS ANGLEYoung Dental Manufacturing Co. 1, LLC · 1978-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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