Z-2571-2018 Class II Terminated
FDA device recall Z-2571-2018 was initiated by Cayenne Medical Inc. on October 10, 2013 and is designated Class II. Reason for recall: A review of complaints identified a trend for drills breaking. The recall status is terminated (terminated February 26, 2019). Affected quantity: 229 devies total.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- October 10, 2013
- Termination Date
- February 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 229 devies total
Product Description
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
Reason for Recall
A review of complaints identified a trend for drills breaking.
Distribution Pattern
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.
Code Information
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