Facility

KICO KNEE INNOVATION COMPANY

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)	3013552417
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	Unit 1, 25 Frenchs Forest Rd E Frenchs Forest New South Wales, AU 2086
Registration status	Active · expires 2026
Parent company	Kico Knee Innovation Company (owner-operator 10054916)
Brand names	ARVIS Surgical Navigation System

Activity by year

Recalls (3)

Devices registered here (1)

Orthopedic Augmented Reality
Product code SBF (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IIOngoing2026-07-13
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Class IIOngoing2026-04-23
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
Class IIOngoing2025-09-19
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

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. “KICO KNEE INNOVATION COMPANY (FEI 3013552417) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013552417-kico-knee-innovation-company/

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