Device Recall Trial Shell component of the accessory kit to the Shoulder Prosthesis Stem

  • Model / Serial
    178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
  • Product Description
    AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • Manufacturer Parent Company (2017)
  • Source
    USFDA