BEUDAMED
    FDA Recall Terminated

    Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted Ball, 4-Series.***Use with***SHORT Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049623***. Cutting and Shaping bone including bones of the spine and cranium.

    Recall: Z-3192-2011 · Initiated May 9, 2011

    Recall

    Recall Number
    Z-3192-2011
    Event Number
    58985
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 9, 2011
    Posted
    September 13, 2011
    Terminated
    February 15, 2012
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted Ball, 4-Series.***Use with***SHORT Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049623***. Cutting and Shaping bone including bones of the spine and cranium.

    Reason

    The Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #'s C323023789, C403026551, C473028567, C403026563, D153034013, D173034385, and C363024789, because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to

    Action

    The Anspach Effort, Inc. sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated May 27, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and to segregate any affected product found. A Customer Response Form was attached for customers to complete and return to the firm via fax at 1-800-327-6661. Contact Anspach Customer Support at 800-327-6887 for questions regarding this recall.

    Distribution

    Worldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.

    Quantity

    30