FDA recall Z-2571-2018

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 for recall

A review of complaints identified a trend for drills breaking.

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.

Key facts

Status

Terminated

Initiation date

2013-10-10

Report date

2018-08-08

Termination date

2019-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Scottsdale, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2571-2018