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
Recall
- Recall Number
- Z-2293-2026
- Event Number
- 98804
- Firm
- Kico Knee Innovation Company
- FEI Number
- 3013552417
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- April 23, 2026
- Posted
- June 2, 2026
- Address
- 20 Bridge St, Building 1 Suite 3, Pymble Australia
Description
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
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.
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.
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124 kits