Device Recall Integra Leyla Ball Joint Clamp

  • Model / Serial
    Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.
  • Product Description
    Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. || The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
  • Source
    USFDA