Class II — Cayenne Medical Inc.
| Recalling firm | CAYENNE MEDICAL, INC. |
|---|---|
| Registered facility | CAYENNE MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A review of complaints identified a trend for drills breaking. |
| 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 |
| Quantity | 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. |
| Initiated | 2013-10-10 |
| Classified | 2018-07-28 |
| Terminated | 2019-02-26 |
| Recall number | Z-2571-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cayenne Medical Inc. (Z-2571-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80420/
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