Facility

CAYENNE MEDICAL, INC.

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006108336
Establishment type	Manufacture Medical Device
Location	16597 N. 92ND STREET SCOTTSDALE, AZ, US 85260
Registration status	Active · expires 2026
Parent company	CAYENNE MEDICAL, INC. (owner-operator 9091610)
Brand names	AFX® Femoral Implant with Inserter, 9mm x 25mm - CM-2509AFX; AFX® Femoral Implant with Inserter, 10mm x 25mm - CM-2510AFX

Activity by year

Recalls (3)

Devices registered here (1)

Fastener, Fixation, Nondegradable, Soft Tissue
Product code MBI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

Class IITerminated2013-10-10
A review of complaints identified a trend for drills breaking.
Class IITerminated2013-07-11
Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
Class IITerminated2010-04-28
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.

All facilities operated by CAYENNE MEDICAL, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CAYENNE MEDICAL, INC. (FEI 3006108336) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006108336-cayenne-medical-inc/

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