Device Recall Cutting Edge Acetabular Spherical Reamer

  • Model / Serial
    Catalog Number 2102-0444 Lot number V2010068 No 510 K number No expiration date
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. || The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures, reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone stock, bone quality, desired level of press fit, and proper amount of reaming.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
  • Source
    USFDA