Atlanta, GA, United States
CARESTREAM DENTAL, LLC recalls
1 recall recorded since 2018, most recently on 15 February 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 15 February 2021
- Terminated
- 14 January 2023
- Reason
- The mirror may become detached and fall from the unit
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1268-2021
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.