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CARESTREAM DENTAL, LLC Recall 87443

Description: 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.

CARESTREAM DENTAL, LLC Recall 87443 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1268-2021
Event ID87443
Event DescriptionCarestream 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.
Product TypeDevices
DistributionWorldwide 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.
Quantity11400 devices
Recall ReasonThe mirror may become detached and fall from the unit
Device Classification20210324
Device Code InfoAll lot numbers
Center Classification Date20210317
Recall Initiation Date20210215
Recalling FirmCARESTREAM DENTAL, LLC
Initial Notification Letter
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