BEUDAMED
    FDA Recall Terminated

    Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where x-ray imaging modalities will be used.

    Recall: Z-2336-2010 · Initiated May 19, 2010

    Recall

    Recall Number
    Z-2336-2010
    Event Number
    55852
    Firm
    Integra LifeSciences Corporation
    FEI Number
    3004608878
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 19, 2010
    Posted
    September 9, 2010
    Terminated
    October 27, 2011
    Address
    4900 Charlemar Dr, Bldg A, Cincinnati, OH, 45227-1402

    Description

    Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where x-ray imaging modalities will be used.

    Reason

    Storage case incorrectly labeled. The labels were for the Infinity XR2 Skull Clamp storage containers but were inadvertently placed on the Infinity XR2 Base Unit storage cases.

    Action

    The firm, Integra Life Sciences Corporation,contacted their customers via telephone and Field Correction Letter on May 19, 2010 to notify their customers of the problem. The firm indicated that their sales representatives will visit the consignees affected, correct the case labeles according to the specific instructions indicated, revise their account tracebility records to reflect the labeling change, then, sign and return the Acknowledgement of Reciept and Return Form for confirmation. For questions regarding the correction, please contact Integra Life Sciences Corporation at (877) 44-1114 or (513) 533-7923.

    Distribution

    Product was shipped to the following states: IN, MO, NJ, TX and VA. Product was also sold in Belgium, Canada and New Zealand.

    Quantity

    13 Units