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Recall Observatory FDA recall evidence

Device 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

Z-2571-2018

October 10, 2013

Class II

Product summary

Firm
Cayenne Medical Inc.
Event
Event 80420
Status
Terminated
Classification
Class II
Quantity
229 devies total
Official record key
device-enforcement:Z-2571-2018

Official wording

Reason: A review of complaints identified a trend for drills breaking.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A review of complaints identified a trend for drills breaking.