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U.S. Department of Health and Human Services

Class 2 Device Recall Quattro Spade Drill

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  Class 2 Device Recall Quattro Spade Drill see related information
Date Initiated by Firm October 10, 2013
Create Date July 28, 2018
Recall Status1 Terminated 3 on February 26, 2019
Recall Number Z-2571-2018
Recall Event ID 80420
Product Classification Bit, drill - Product Code HTW
Product 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
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 
Recalling Firm/
Manufacturer		 Cayenne Medical Inc.
16597 N 92nd St Ste 101
Scottsdale AZ 85260-1847
For Additional Information Contact Kevin Escapule
574-372-4487
Manufacturer Reason
for Recall		 A review of complaints identified a trend for drills breaking.
FDA Determined
Cause 2		 Device Design
Action Customers were contacted on approximately 10/10/2013 and were instructed to return any affected products on hand.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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