Medtronic Sofamor Danek USA Inc recalls TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
- Recall date
- July 18, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2636-2016
- FDA classification
- Class II
- Brand / firm
- Medtronic Sofamor Danek USA Inc
- Sold / distributed
- AR, MN,MA
Why it was recalled
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
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