BEUDAMED
    FDA Recall Terminated

    Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW

    Recall: Z-0813-2015 · Initiated November 6, 2014

    Recall

    Recall Number
    Z-0813-2015
    Event Number
    69719
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    KWD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 6, 2014
    Posted
    December 16, 2014
    Terminated
    August 21, 2015
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW

    Reason

    Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.

    Action

    The firm sent out written notification of the recall on 11/6/14. The letter instructed the consignees to quarantine and return any affected product.

    Distribution

    WA, Australia, and France

    Quantity

    19 units