Z-2293-2026Class II

Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500...

Name: Z-2293-2026 Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500...
Creator: Kico Knee Innovation Company
Published: 2026-04-23
License: https://open.fda.gov/license/

Kico Knee Innovation Company / initiated 2026-04-23 / Open, Classified / root cause: design

FDA source

Kico Knee Innovation Company began a recall of Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B... on 2026-04-23. FDA classified it as Class II and gives the reason as "The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2293-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-23
Posted: 2026-06-02
Recalling firm: Kico Knee Innovation Company
Product: Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
Root cause tag: design
FDA root cause: Device Design
Action: On April 27, 2026 Kico Knee Innovation issued a Urgent: Medical Device Recall to affected consignees via E-Mail. Kico ask consignees to take the following actions: 1. Instruments can continue to be used as is, given none of the failure modes are exhibited. 2. This notice needs to be passed on to all those who need to be aware within your organization or where the potentially affected devices have been transferred. 3. Please retain a copy of this letter, place a copy where devices are stored, and keep a copy of the acknowledgement form for your files. 4. Complete the attached Acknowledgement Form immediately and return it email to [email protected] 5. Instruments should always be visually inspected prior to use as stated in the Instructions for Use.
Quantity in commerce: 124 kits
Distribution: Worldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI, CO, MT, FL, IL, NY, AL, WI, NE, AZ, MN, VT, NH, MD, RI, MA, NJ, PA, KS, WA, ID, OR, TN, VA, PR and the countries of Australia, France, Germany, Italy.
Product codes and lots: All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2293-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2292-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-02
Z-2293-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-02

Product code OLO

K203115Class IIARVIS Surgical Navigation SystemInsight Medical Systems, Inc. / cleared 2021-07-14

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)