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 symptomatic sequelae after radial head resection.
Recall
- Recall Number
- Z-0582-2015
- Event Number
- 69580
- Firm
- Skeletal Dynamics
- FEI Number
- 3006742481
- Product Code
- KWI
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 16, 2014
- Posted
- December 12, 2014
- Terminated
- December 14, 2016
- Address
- 8905 Sw 87th Ave, Ste 201, Miami, FL, 33176-2227
Description
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 symptomatic sequelae after radial head resection.
Report received where the Align Radial Stem fractured.
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 included with instructions to return the signed form to acknowledge the receipt and understanding of the new warning. Product labeling has been revised to include these labels in future shipments. Customers with questions were instructed to contact Customer Service at 877-753-5396 for assistance. For questions regarding this recall call 305-596-7585, ext 7026.
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.
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