Mako Surgical Corporation recalls RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and i…

Recall date

February 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1583-2016

FDA classification

Class II

Brand / firm

Mako Surgical Corporation

Sold / distributed

Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.

Why it was recalled

Potential disassociation of the orientation pin.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.