Kico Knee Innovation Company recalls Arvis Hip & Knee 2.0 Instrument Set
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Arvis Hip & Knee 2.0 Instrument Set2 codes
- 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
Lot / code information
- UDI
- IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563
What the firm 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 Alexander.Borchardt@enovis.com 5. Instruments should always be visually inspected prior to use as stated in the Instructions for Use.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2293-2026
- FDA 510(k) clearance · K203115The device's official FDA premarket clearance record
- FDA device classification · OLOOfficial FDA classification for this device type
- CFR regulation · 21 CFR 882.4560The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Kico Knee Innovation CompanySearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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