Device Recall Howmedica Osteonics

  • Model / Serial
    Catalog No: 8050-5103; 8050-5105; 8050-5107; 8050-5109; 8050-5111; 8050-5113.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The catalog numbers were sent to Howmedica Osteonics Sales Representatives/agents, one Canada Howmedica Sales Representative, and one International Howmedica location in Ireland.
  • Product Description
    Femoral Resection Guide, Scorpio L.R.S. Instrumentation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics, 300 Commerce Court, Mahwah NJ 07430
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Code 48681201
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of GA, MA, NC, NY & PA.
  • Product Description
    LFT v40 Femoral Head; Catalog Number 6260-9-032; || V40 CoCr LFit Head 32mm/-4. || Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
  • Manufacturer
  • Model / Serial
    Catalog Number 8000-1089. Lot Number(s): RD6E087, RD6E187; RD6E083; RD6E082; RD6C178; RD5W268; RD5W267; RD5V260; RD5W320; RD5V240; RD5V239; RD5V238; RD5N407; RD5S104; RD5S103; RD5T177; RD5T179; RD5S259; RD5T178; RD5N406; RD5S300; RD5T298; RD5W381; RD6E086; RD6E089; RD6E090; RD6E091; RD6E158; RD6E159; RD6E160; RD6E186.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. || During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03), tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a template size is selected, the device is secured to the plateau with fixation pins, and the tibial punch tower is assembled by placing the tower onto the two small locating pins on the tibial template. A keel punch is then selected, assembled into the channel of the tower, and impacted with a mallet. Depending on the intended implant size, several keel punches of increasing size may be utilized to incrementally enlarge the cavity. Each keel punch is advanced until it fully seats on the tibial template. Tibial preparation is considered complete when the final keel punch fully seats on the tibial template.
  • Manufacturer
  • Model / Serial
    Catalog number 703615
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AL, AZ, IL, KY, LA, NJ, NC, FL, CA, NM, MO, TN, VA, CO, MA, TX, IN and MT.
  • Product Description
    Stryker Howmedica Osteonics Corp. AxSOS System Instrument. || The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy, check the correct depth of the drill, and measure the length of the screw. The Drill Sleeve should now be removed, and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve."
  • Manufacturer
  • Model / Serial
    v40 Hip Stem -Right Size # 3: catalog # 6265-5113 lot code #43317101, v40 Hip Stem -Left Size # 4: catalog #6265-5104 lot code #43316801, lot code 43316901, v40 Hip Stem - Right Size #4: catalog #6265-5114 lot code #43113901
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
  • Manufacturer