The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2292-2026·Announced 2026-06-10

Arvis Hip and Knee 3.0 trackers may show wear and corrosion

Arvis Hip & Knee 3.0 Instrument Sets are being recalled because the V-Block Assembly and Trackers A, B, C and E may show early wear or corrosion on the exposed magnet face.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where surgical navigation components may degrade, a risk of harm with no injuries reported in the source.

Plain-English summary

The Arvis Hip & Knee 3.0 Instrument Set, REF IN-28000, containing components including the Impactor V-Block Assembly (IN-10500), Tracker B (IN-10600), Tracker A (IN-16400), Tracker C (IN-16100) and Tracker E (IN-28050), is being recalled. The action covers 69 units and applies to all lots and serial numbers.

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. The FDA classified the action as Class II.

Distribution was worldwide, covering the United States nationwide including Mississippi, California, Iowa, Indiana, Michigan and Colorado. The instrument sets are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected sets using the REF numbers and UDI codes in the recall notice, quarantine them, and follow the instructions issued by the manufacturer.

The recalled product

Product
Arvis 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-16100, Tracker C; IN-28050, Tracker E
Manufacturer
Kico Knee Innovation Company
Category
Medical Device — Surgical navigation instrument set
Hazard
Affected units
69

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • All Lots/serial Numbers
  • UDI: IN-28000: 00810180350020
  • IN-10500: (01)00810180350686
  • IN-10600 (01)00810180350693
  • IN-16400:(01)00810180350525
  • IN-16100: (01)00810180350563
  • IN-28050: 00810180350051

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Kico Knee Innovation Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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