FDA-Device2014-12-24Class II
RESTORIS PST Straight Shell Inserter 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.
Mako Surgical Corporation
Hazard
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Sold states
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.
Affected count
Total 404
Manufactured in
2555 Davie Rd Ste 110, N/A, Plantation, FL, United States
Products
RESTORIS PST Straight Shell Inserter 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0828-2015Don't want to check this manually?
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