Drug recall
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number…
FDA recall event 72695 · Class II · Arthrosurface, Inc.
Key facts
| Event ID | 72695 |
|---|---|
| Recall numbers | Z-0475-2016 |
| Recalling firm | Arthrosurface, Inc. |
| Product type | Devices |
| 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). |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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. |
| Initiation date | Jun 9, 2014 |
| Report date | Dec 30, 2015 |
| Termination date | Feb 5, 2016 |
| City | Franklin |
| State | MA |
| Country | United States |
| FEI number | 3004154314 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: