Device Recall RESTORIS PST Offset Shell Impactor

  • Model / Serial
    Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Mako Surgical Corporation, 2555 Davie Rd Ste 110, Plantation FL 33317-7424
  • Manufacturer Parent Company (2017)
  • Source
    USFDA