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
FDA Recall Z-2293-2026 · Posted 2026-06-02
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Recalling FirmKico Knee Innovation Company
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2026-04-23
Product Quantity124 kits
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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