Recall Z-1268-2021 ยท NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
CARESTREAM DENTAL, LLC
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.
| Date | Feb 15, 2021 |
| Status | Terminated |
| Reason | The mirror may become detached and fall from the unit |
| Root cause | Device Design |
| Action | The firm initiated the recall by letter on 02/2/2021. The letter explained the problem, requested the consignee cease use of the product and return all affected product. |
| Quantity | 11400 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.