FDA Devices recall · Reported December 30, 2015
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).
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Arthrosurface, Inc. recalled Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi… - a moderate-severity action.
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi… was recalled by Arthrosurface, Inc. in December 30, 2015. Reason: An oversight in the implementation of the design change record resulted in outdated components being shipped …. Check the official notice for the remedy. Verify recall #Z-0475-2016 with the FDA Devices before acting.
The recall
Arthrosurface, Inc. issued this moderate-severity FDA Devices recall-An oversight in the implementation of the design change record resulted in outdated components being shipped ….
- Moderate
- severity level
- 3 units
- affected scope
- Class II
- classification
- December 30, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0475-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0475-2016) was formally reported on December 30, 2015, with the manufacturer initiating the action on June 9, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Arthrosurface, Inc. is listed as the recalling firm, operating out of Franklin, MA. Federal records list the affected scope as 3 units.
The documented reason for this recall is: An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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. Distribution data in the federal record shows the product reached: US Distribution to the states of : PA, WV and CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0475-2016 |
| Date reported | December 30, 2015 |
| Date initiated | June 9, 2014 |
| Recalling firm | Arthrosurface, Inc. |
| Firm location | Franklin, MA |
| Affected scope | 3 units |
| Distribution | US Distribution to the states of : PA, WV and CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0475-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026