Recall Z-0582-2015 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Skeletal Dynamics
Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation and resistance to conservative treatment. Intended use is also for primary replacement after fracture of the radial head and sym
| Date | Dec 12, 2014 (initiated Oct 16, 2014) |
| Status | Terminated |
| Reason | Report received where the Align Radial Stem fractured. |
| Root cause | Device Design |
| Action | Skeletal Dynamic sent an Urgent Medical Device Safety Alert dated October 16, 2014, to all affected customers via certified mail. The Safety Alert included the warning "that radial head prostheses cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue. Failure of the component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union or excessive loads (estimated body weight equivalent of 350 lbs or greater)" with instructions to notify any surgeons that have used the product. A response form has been include |
| Quantity | 1700 |
| Distribution | Nationwide Distribution including GA, NJ, NM, IL, CA, OK, CO, NY, LA, OH, FL, VA, MD, MS, TX, IA, AL, WA, TN, ME, CT, WI, AZ, NE, SC, NC and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092721 | ALIGN RADIAL HEAD SYSTEM Skeletal Dynamics, LLC, Aug 3, 2010 |