Cayenne Medical Inc.: Medical Device Recall in 2018 - (Recall #: Z-2571-2018)
See the recall detail below. You can also see other recalls from the same firm in 2018.
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
Class II
A review of complaints identified a trend for drills breaking.
a. Model Number CM-9300, Lot Number 2211211, 4271209, LNR, 7181408, 1221502, 4071521, 5091602, 7221613, 8301608, 9271623, 9271619, 9271621, 59068, 59069; b. Model Number CM-9324, Lot Number LNR, LRN, 11071203, 11281201, 4031303, 6061310, 9061302, 10081305, 1061401, 7181406, 9161409, 1221503, 1221501, 4071522, 6241501, 11051503, 3011650, 5091601, 7111613, 8301609, 9271618, 9271620, 11463, 11141
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.
Voluntary: Firm initiated