Recall Z-2780-2017 ยท HSB Rod, Fixation, Intramedullary And Accessories
Ortho Solutions Inc
Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
| Date | Apr 19, 2017 |
| Status | Terminated |
| Reason | There is a material mislabeling of the AFN End Cap. |
| Root cause | Error in labeling |
| Action | Orthosol notified their customers on 4/19/2017 via USPS. |
| Quantity | 277 units |
| Distribution | US distribution to MD, NY & PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121575 | OXFORD ANKLE FUSION NAIL(AFN) SYSTEM Ortho Solutions Limited, Sep 14, 2012 |