Recall Z-2571-2018— Cayenne Medical Inc.

Name: FDA recall Z-2571-2018
Creator: U.S. Food and Drug Administration
Published: 2013-10-10

Class II · Terminated

Class II FDA medical device recall by Cayenne Medical Inc., initiated 2013-10-10, terminated 2019-02-26. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: A review of complaints identified a trend for drills breaking..

Recalling firm: Cayenne Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Terminated: 2019-02-26
Firm location: Scottsdale, AZ, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.