FDA DevicesClass II
Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the followi...
Published: June 10, 2026Recall ID: Z-2293-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Pymble |
| Event id | 98804 |
| Address 1 | Suite 3, Building 1, 20 Bridge St |
| Code info | All Lots/serial Numbers; UDI: IN-28000: 00810180350020; IN-10500: (01)00810180350686; IN-10600 (01)00810180350693; IN-16400:(01)00810180350525; IN-16100: (01)00810180350563; |
| Postal code | N/A |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 124 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260423 |
| Initial firm notification | Letter |
| Center classification date | 20260602 |
Overview
- Recalling FirmKico Knee Innovation Company
- StatusOngoing
- Risk LevelClass II
- 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.