Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Total Toe Instrument Kit Recalled by Arthrosurface, Inc. Due to An oversight in the implementation of the design...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arthrosurface, Inc. directly.
Affected 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).
Quantity: 3 units
Why Was This 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An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Where Was This Sold?
This product was distributed to 3 states: CA, PA, WV
About Arthrosurface, Inc.
Arthrosurface, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report