FDA Device recall Z-0475-2016
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question…
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question… by Arthrosurface, citing an oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0475-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-09 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arthrosurface |
| Distribution | CA, PA, WV |
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
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Identifiers
| code_info | SN 000242 SN 000244 SN 000246 SN 000247 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Arthrosurface
- Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - Athrosurface 40mm 13.75x31mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface - Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component
FDA Device · Class II · 2015-02-18 · Arthrosurface
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0475-2016%22
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