Arthrosurface, Inc. recalls Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The c…
- Recall date
- June 9, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0475-2016
- FDA classification
- Class II
- Brand / firm
- Arthrosurface, Inc.
- Sold / distributed
- US Distribution to the states of : PA, WV and CA.
Why it was recalled
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
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