Arvis Hip and Knee 3.0 trackers may show wear and corrosion

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

• wear
• corrosion
• surgical-navigation
• class-ii

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

Related recalls