Device Recall Keramos CeramiconCeramic Acetabular System

  • Model / Serial
    Lot numbers 276202 and 270512
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Iowa, Florida, California, Arizona, South Dakota, Utah, Missouri, Texas, and Massachusetts, Maryland, Oklahoma, Nevada
  • Product Description
    Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA