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Mako Surgical Corporation recalls RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surg
Recalled December 24, 2014 · FDA recall Z-0830-2015 · Mako Surgical
Hazard
MAKO has identified the potential that the shell impactors may be damaged intraoperatively. · FDA Class II
Units
Total 404
Sold at
Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.
Description
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Product
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed 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 →