BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2056-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2056-2013
    Event ID
    65824
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 17, 2013
    Classification Date
    August 26, 2013
    Termination Date
    October 1, 2014
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    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.

    Reason

    As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.

    Code Info

    Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.

    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.

    Quantity

    65