Device Recall SOL SYS 8IN CALC 1.5/18.0

Product Code: 157215180 and Lot codes: 116897, 126366, A63GP1000, A63GPA000, AP2BD1000, B19CL1000, B19CLA000, B19CLC000, B3DE71000, B3DE7A000, B5CA41000, C1PDC1000, C4YBG1000, C4YBGB, CB1EX1000, CC5JR1000, CH1AC1000, CH7EG1000, CL5PF1000, DD3BT1000, DD3BTA000, DH9JW1000, E1KKA1000, EC8DY1000, ET4FH1000, FB8RA1, FG9KV1, X2HD31000, X2HD41000, X2HD4B000, X2HD4C000, X2HD4D000, X2HD51000, X2HD5A000, X5REB1000, X5REBB000, XY7F71000, YA6GS1000, YG3DE1000, YH8AK1000, YH8AKA000, and Z5VAP1000.

Orthopedic Devices

2

Yes

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

SOL SYS 8IN CALC 1.5/18.0 || 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.