Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic disabiliti

FDA device recall Z-0582-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Skeletal Dynamics

Reason for recall

Report received where the Align Radial Stem fractured.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KWI

Quantity affected

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.

Date initiated

2014-10-16

Date posted

2014-12-12

Date terminated

2016-12-14

Location

Miami, FL

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