Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

FDA Recall Z-2436-2019 · Posted None

Recalling FirmColtene /Whaledent AG
Recall StatusTerminated
Product CodeEJL
Date Initiated2019-07-19
Date Terminated2021-04-30
Product Quantity20 units of 5 burs/unit

Reason for Recall

A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.

Firm Action

The firm initiated the recall by email on 07/19/2019 requesting that the consignee return any unused product for replacement.

Root Cause

Error in labeling

Distribution Pattern

GA

Official Source

View FDA Recall →

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

↑