BEUDAMED
    FDA Recall Terminated

    Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.

    Recall: Z-0129-2014 · Initiated August 28, 2013

    Recall

    Recall Number
    Z-0129-2014
    Event Number
    66196
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    NDG
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 28, 2013
    Posted
    November 1, 2013
    Terminated
    April 30, 2015
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.

    Reason

    Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing, to provide statisti

    Action

    The firm, Zimmer Inc., sent a letter entitled "Voluntary Recall of Ti-VFxII Condylar Tube Plates and Ti-Washers" dated September 12, 2013 to its customer. The letter described the product, problem and action to be taken. The customer was instructed to immediately discontinue use of the listed products. A Sales representatives from Zimmer K.K. or agencies will be in contact with you. Zimmer Inc. is planning to resume product manufacturing upon the completion of package validation review. Zimmer K.K. will contact you when a detailed schedule has been determined. If you have any questions, contact Zimmer K.K. Safety Office (9:00 to 17:00; closed weekends and public holidays) TEL: 0120-015-180.

    Distribution

    International distribution: Japan only.

    Quantity

    2,632 devices