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Recall Observatory FDA recall evidence

Device product

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.

Z-1268-2021

February 15, 2021

Class II

Product summary

Firm
CARESTREAM DENTAL, LLC
Event
Event 87443
Status
Terminated
Classification
Class II
Quantity
11400 devices
Official record key
device-enforcement:Z-1268-2021

Official wording

Reason: The mirror may become detached and fall from the unit

Code information: All lot numbers

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The mirror may become detached and fall from the unit