Cayenne Medical Recalls Quattro Link Drills Due to Breakage Trend
Cayenne Medical Inc. is recalling 229 Quattro Link drills because a review of complaints identified a trend for the devices breaking.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (drills breaking) in a medical device, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cayenne Medical Inc. is recalling 229 units of Drill (Fluted-Hard Bone) for Quattro Link 2.9mm. The devices are labeled as either Quattro Spade Drill, for 2.9mm, Model Number CM-9300, or Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324.
The recall was initiated after a review of complaints identified a trend for the drills breaking. The affected devices were distributed in the United States 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, and WI.
Healthcare providers and consumers should stop using the affected devices and contact Cayenne Medical Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- Cayenne Medical Inc.
- Hazard
- Affected units
- 229
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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