Device Recall Equinoxe Reverse Compression Screw

  • Model / Serial
    Sizes:  4.5x18mm Catalog # 320-20-18 Serial Range 1610445-2381151 4.5x22mm Catalog # 320-20-22 Serial Range 1610391-2381151 4.5x26mm Catalog # 320-20-26 Serial Range 1611237-2381151 4.5x30mm Catalog # 320-20-30 Serial Range 1617556-2381151 4.5x34mm Catalog # 320-20-34 Serial Range 1611290-2381151 4.5x38mm Catalog # 320-20-38 Serial Range 1610260-2381151 4.5x42mm Catalog # 320-20-42 Serial Range 1630006-2381151 4.5x46mm Catalog # 320-20-46 Serial Range 1644317-2381151
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
  • Product Description
    Equinoxe Reverse Compression Screw || Intended for Primary and Reverse Total Shoulder Arthroplasty.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
  • Source
    USFDA