FDA-Device2015-12-30Class II
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).
Arthrosurface, Inc.
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An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Sold states
US Distribution to the states of : PA, WV and CA.
Affected count
3 units
Manufactured in
28 Forge Pkwy, N/A, Franklin, MA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0475-2016Don't want to check this manually?
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