BEUDAMED
    FDA Recall Terminated

    MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.

    Recall: Z-0797-2010 · Initiated January 8, 2010

    Recall

    Recall Number
    Z-0797-2010
    Event Number
    54356
    Firm
    Gyrus ACMI Corporation
    FEI Number
    3003790304
    Product Code
    ETD
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    January 8, 2010
    Posted
    March 4, 2010
    Terminated
    July 27, 2010
    Address
    136 Turnpike Rd, Southborough, MA, 01772-2118

    Description

    MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.

    Reason

    Units of the product in lot MH136952 may have been shipped without being sterilized.

    Action

    The firm initiated their recall on 01/04/2010 by telephone or visit to their consignees. A follow-up Urgent: Medical Device Recall correspondence, dated 1/14/2010, was sent on 01/27/2010, return receipt requested, to both the consignees and the implanting surgeons. The follow-up letter identified the affected product and described the issue. Customers are to immediately cease any further use of any affected product and quarantine it. Also, they are to obtain a Return Goods Authorization and return the affected product to the firm. The reply form should be completed and also returned. Questions should be directed to customer service at 1-800-773-4301.

    Distribution

    Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.

    Quantity

    19 boxes of 6 units