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Arthrosurface, Inc. recalls Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 Th
Recalled December 30, 2015 · FDA recall Z-0475-2016 · Arthrosurface
Hazard
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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. · FDA Class II
Units
3 units
Sold at
US Distribution to the states of : PA, WV and CA.
Description
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Product
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).
Manufacturer(s)
Arthrosurface, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →