BEUDAMED
    FDA Recall Terminated

    RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas

    Recall: Z-0809-04 · Initiated September 30, 2003

    Recall

    Recall Number
    Z-0809-04
    Event Number
    28512
    Firm
    Centerpulse Orthopedics, Inc
    FEI Number
    2935620
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 30, 2003
    Posted
    July 20, 2004
    Terminated
    November 4, 2004
    Address
    9900 Spectrum Dr, Austin, TX, 78717-4555

    Description

    RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas

    Reason

    Compalints of acetabular shell disassociating with the bone.

    Action

    The firm called and issued letters on September 30, 2003 informing physicians of a complaint received. The letter requested that the physicians discontinue use of the device until and investigation could be conducted. On 03/8/2004 the firm issued a letter to Zimmer distributors to return all inventory.

    Distribution

    Physicians in the following areas: CA, Washington D.C., MD, LA, ID, and WA

    Quantity

    145 units