Device Recall SOL SYS R 9IN CALC 2.25/18

  • Model / Serial
    Product Code: 157226180 and Lot codes: 118843, A31E61000, B12LF1000, B2PAW1000, BC4HS1000, C5FH91000, C76FD1000, CK3FM1000, DG4FX1000, E6BKV1, ER8L21000, X34C41000, X49FG1000, X4SE81000, X4SE91000, X53B21000, YF4A61000, YF4A71000, YF4A7A000, YG4AH1000, YG4AHA000, YH9E51000, and YH9E5A000.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR
  • Product Description
    SOL SYS R 9IN CALC 2.25/18 || Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. || Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
  • Source