Signature Orthopedics Pty Limited recalls Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
- Recall date
- December 10, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0833-2019
- FDA classification
- Class II
- Brand / firm
- Signature Orthopedics Pty Limited
- Sold / distributed
- US Nationwide Distribution in the states of FL, NY, and TN
Why it was recalled
Product mix up
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
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