RSP Humeral Socket Reamer (Size 32 SML)

  • Modèle / numéro de série
    All lots are being recalled.  DJO Surgical Part Number 804-02-013, 804-02-014, and 804-02-015
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AR, AZ, CA, CO, FL,GA, ID, IN, IL, LA, MA, MD, ME, MI, MO, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, and WI and Internationally toGermany, South America, Italy, Saudi Arabia, United Kingdom, and Canada.
  • Description du dispositif
    RSP Humeral Socket Reamer (Size 32 SML): || DJO Surgical Instruments and Instrument Cases || DJO surgical || Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 || Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696. || The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA