Total Toe Instrument Kit — Class II medical device recall Z-0475-2016
Terminated recall by Arthrosurface, Inc., reported 2015-12-30, distributed in CA, PA, WV. An oversight in the implementation of the design change record resulted in outdated components being shipped t
| Recall number | Z-0475-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrosurface, Inc., Franklin, MA, United States |
| Recall initiated | 2014-06-09 |
| Classified | 2015-12-23 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-02-05 |
| Distributed | CA, PA, WV |
| Quantity | 3 units |
| Model numbers | 15MM, 2009-4001, 9000-3002 |
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).
Reason for recall
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0475-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.