CARESTREAM DENTAL, LLC recalls Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographi…

Recall date

February 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1268-2021

FDA classification

Class II

Brand / firm

CARESTREAM DENTAL, LLC

Sold / distributed

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.

Why it was recalled

The mirror may become detached and fall from the unit

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.