Recall Z-0475-2016 ยท LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Arthrosurface, Inc.
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).
| Date | Dec 23, 2015 (initiated Jun 9, 2014) |
| Status | Terminated |
| Reason | An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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. |
| Root cause | Process change control |
| Action | The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call (508) 520-3003. |
| Quantity | 3 units |
| Distribution | US Distribution to the states of : PA, WV and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132496 | ARTHROSURFACE TOEMOTION Arthrosurface, Inc., Feb 26, 2014 |