Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200… recallZ-2293-2026 · Kico Knee Innovation Company · initiated Apr 23, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Kico Knee Innovation Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2293-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 23, 2026
- Posted by the FDA
- Jun 2, 2026
- Recalling firm
- Kico Knee Innovation Company
- Quantity
- 124 kits
- Product code
- OLO
- FDA submissions
- K203115
- 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 description
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
Code information (models, lots, serial numbers)
All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563;
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARVIS ® IN-28000Kico Knee Innovation Company Pty Limited · Orthopedic Augmented Reality2 recalls0 reports
- ARVIS ® IN-16400Kico Knee Innovation Company Pty Limited · Orthopedic Stereotaxic Instrument2 recalls0 reports
- ARVIS ® IN-16100Kico Knee Innovation Company Pty Limited · Orthopedic Stereotaxic Instrument2 recalls0 reports
- ARVIS ® IN-10500Kico Knee Innovation Company Pty Limited · Orthopedic Stereotaxic Instrument2 recalls0 reports
- ARVIS ® IN-10600Kico Knee Innovation Company Pty Limited · Orthopedic Stereotaxic Instrument2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98804).
- Z-2292-2026 · Open, ClassifiedArvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page