[pending] Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10
Pending LLM rewrite. Source: FDA_DEVICE Z-2293-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 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
- Manufacturer
- Kico Knee Innovation Company
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- All Lots/serial Numbers
- UDI: IN-28000: 00810180350020
- IN-10500: (01)00810180350686
- IN-10600 (01)00810180350693
- IN-16400:(01)00810180350525
- IN-16100: (01)00810180350563
Distribution
Distributed nationwide across the United States.
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