Z-1268-2021 Class II Terminated
FDA device recall Z-1268-2021 was initiated by CARESTREAM DENTAL, LLC on February 15, 2021 and is designated Class II. Reason for recall: The mirror may become detached and fall from the unit The recall status is terminated (terminated January 14, 2023). Affected quantity: 11400 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 15, 2021
- Termination Date
- January 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11400 devices
Product 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.
Reason for Recall
The mirror may become detached and fall from the unit
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.
Code Information
All lot numbers