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Terminated

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

FDA Recall Z-2571-2018 · Posted None

Recalling FirmCayenne Medical Inc.
Recall StatusTerminated
Product CodeHTW
Date Initiated2013-10-10
Date Terminated2019-02-26
Product Quantity229 devies total

Reason for Recall

A review of complaints identified a trend for drills breaking.

Firm Action

Customers were contacted on approximately 10/10/2013 and were instructed to return any affected products on hand.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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