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Mako Surgical Corporation recalls RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and
Recalled May 4, 2016 · FDA recall Z-1583-2016 · Mako Surgical
Hazard
Potential disassociation of the orientation pin. · FDA Class II
Units
96
Sold at
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.
Description
Potential disassociation of the orientation pin.
Product
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.
Manufacturer(s)
Mako Surgical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →