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U.S. Department of Health and Human Services

Class 2 Device Recall ARVIS Surgical Navigation System (Impactor VBlock Assembly and Trackers A, B, C and E)

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 Class 2 Device Recall ARVIS Surgical Navigation System (Impactor VBlock Assembly and Trackers A, B, C and E)see related information
Date Initiated by FirmApril 23, 2026
Date PostedJune 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2293-2026
Recall Event ID 98804
510(K)NumberK203115 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductArvis 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
Code Information All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563;
FEI Number 3013552417
Recalling Firm/
Manufacturer		 Kico Knee Innovation Company
Suite 3, Building 1, 20 Bridge St
Pymble Australia
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce124 kits
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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