Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Bloc
FDA device recall Z-2292-2026 · posted 2026-06-02 · Open, Classified
Recall details
- Recalling firm
- Kico Knee Innovation Company
- Reason for recall
- 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.
- Action taken
- 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 Alexander.Borchardt@enovis.com 5. Instruments should always be visually inspected prior to use as stated in the Instructions for Use.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 69 units
- 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 Australi
- Date initiated
- 2026-04-23
- Date posted
- 2026-06-02
- Location
- Pymble, Australia
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