BEUDAMED
    FDA Recall Terminated

    10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

    Recall: Z-2604-2010 · Initiated July 1, 2010

    Recall

    Recall Number
    Z-2604-2010
    Event Number
    56522
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    July 1, 2010
    Posted
    September 28, 2010
    Terminated
    August 20, 2012
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.

    Reason

    The affected instruments are discolored and/or have a sticky residue on the end.

    Action

    The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755.

    Distribution

    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.

    Quantity

    116