CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
Total Toe Instrument Kit, Labeled in part recalled by Arthrosurface
Arthrosurface is recalling Total Toe Instrument Kit, Labeled in part: "Instrument Set Toe, Dorsal Flange Combi", distributed in California, Pennsylvania, West Virginia. The recall was initiated on 9 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0475-2016
- FDA event ID
- 72695
- Recalling firm
- Arthrosurface, Franklin, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jun 2014
- FDA classified
- 23 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 Jun 2014 | Recall initiated by company | |
| 23 Dec 2015 | Classified by FDA | +562 days |
| 30 Dec 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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).
Where it was distributed
US Distribution to the states of : PA, WV and CA.
Questions about this recall
Is Total Toe Instrument Kit, Labeled in part: "Instrument Set Toe, Dorsal Flange Combi" recalled?
Yes. Arthrosurface recalled Total Toe Instrument Kit, Labeled in part: "Instrument Set Toe, Dorsal Flange Combi" on 9 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-0475-2016.
Why was it 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An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Which lots are affected?
SN 000242 SN 000244 SN 000246 SN 000247
Where was it sold?
US Distribution to the states of : PA, WV and CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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