Class II — Arthrosurface, Inc.
| Recalling firm | Arthrosurface, Inc. |
|---|---|
| Registered facility | ARTHROSURFACE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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). |
| Quantity | 3 units |
| Distribution | US Distribution to the states of : PA, WV and CA. |
| Initiated | 2014-06-09 |
| Classified | 2015-12-23 |
| Terminated | 2016-02-05 |
| Recall number | Z-0475-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Arthrosurface, Inc. (Z-0475-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72695/
Alerts for Arthrosurface, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.