Recall Z-1124-2017 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Synthes (USA) Products LLC
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
| Date | Dec 29, 2016 |
| Status | Terminated |
| Reason | There is the possibility that the radial stem may loosen post-operatively at the stem bone interface. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Notice was mailed to consignees explaining the reason for the recall. Customers were asked to immediately review their inventories for the affected product and complete and return the Verification form that was included with the notification and return any of the affected product that was found. |
| Quantity | 50,311 units |
| Distribution | United States Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM Synthes USA, LLC, Jun 19, 2012 |