Recall Z-1238-2013 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Synthes USA HQ, Inc.
Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.
| Date | May 3, 2013 (initiated Feb 22, 2013) |
| Status | Terminated |
| Reason | The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events. |
| Root cause | Device Design |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated February 22, 2013, to all affected consignees. The letter requested consignees examine their inventory, remove them from use and return them to Synthes. Customers were asked to complete the attached Verification Section at the end of the letter indicating whether or not they have any of the affected product. For questions customers were instructed to call 610-719-5450 or email FieldAction@synthes.com. For questions regarding this recall call 610-719-5000. |
| Quantity | 417 |
| Distribution | Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI. |
| 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 |