Recall Z-2571-2018 ยท HTW Bit, Drill
Cayenne Medical Inc.
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
| Date | Oct 10, 2013 |
| Status | Terminated |
| Reason | A review of complaints identified a trend for drills breaking. |
| Root cause | Device Design |
| Action | Customers were contacted on approximately 10/10/2013 and were instructed to return any affected products on hand. |
| Quantity | 229 devies total |
| Distribution | US distribution to AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.