BEUDAMED
    FDA Recall Terminated

    Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

    Recall: Z-2153-2011 · Initiated January 26, 2011

    Recall

    Recall Number
    Z-2153-2011
    Event Number
    58318
    Firm
    Surgical Design Inc
    FEI Number
    3001236105
    Product Code
    HFX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 26, 2011
    Posted
    May 6, 2011
    Terminated
    June 21, 2013
    Address
    7351 Lockport Pl, Ste D, Lorton, VA, 22079-1571

    Description

    Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

    Reason

    Medical device used in surgical procedure is defective and may break during use.

    Action

    Surgical Design, Inc. sent a Customer letter dated February 23, 2011, informing them of the affected product and providing instructions for its specific consignees. The instructions to the User is to please check your inventory to determine whether any Circumcision Clamps bought directly match those on your shelves. Please fill out the form and mail it to Surgical Design at the address on the form. If any clamps from the affected lots remain in your inventory, please ship them back to Surgical Design, noting the number being returned on the Reply form. These are the affected Lots. 100210 (1.3cm) 100211 (1.1cm) and 100060409 (1.3cm) If you have any further questions, please call (703) 541-0196.

    Distribution

    Class 2 Recall -- Nationwide Distribution.

    Quantity

    6100 clamps