Z-2571-2018Class II

Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number...

Name: Z-2571-2018 Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number...
Creator: Cayenne Medical Inc.
Published: 2013-10-10
License: https://open.fda.gov/license/

Cayenne Medical Inc. / initiated 2013-10-10 / Terminated / root cause: design

FDA source

Cayenne Medical Inc. began a recall of 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... on 2013-10-10. FDA classified it as Class II and gives the reason as "A review of complaints identified a trend for drills breaking". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2571-2018
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Posted: 2018-07-28
Terminated: 2019-02-26
Recalling firm: Cayenne Medical Inc.
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
Product code: HTW Bit, Drill
Reason for recall: A review of complaints identified a trend for drills breaking.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2571-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2571-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)