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Terminated

Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.

FDA Recall Z-1268-2021 · Posted None

Recalling FirmCARESTREAM DENTAL, LLC
Recall StatusTerminated
Product CodeNOF
Date Initiated2021-02-15
Date Terminated2023-01-14
Product Quantity11400 devices

Reason for Recall

The mirror may become detached and fall from the unit

Firm Action

The firm initiated the recall by letter on 02/2/2021. The letter explained the problem, requested the consignee cease use of the product and return all affected product.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada.

Official Source

View FDA Recall →

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

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