BEUDAMED
    FDA Recall Terminated

    Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.

    Recall: Z-2753-2011 · Initiated May 24, 2011

    Recall

    Recall Number
    Z-2753-2011
    Event Number
    59024
    Firm
    Kapp Surgical Instrument Inc
    FEI Number
    1522875
    Product Code
    NEU
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 24, 2011
    Posted
    July 7, 2011
    Terminated
    February 19, 2013
    Address
    4919 Warrensville Center Rd, Warrensville Heights, OH, 44128-4353

    Description

    Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.

    Reason

    During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. Kapp Surgical decided to conduct the recall because we cannot be sure that incorrect instructions were not shipped.

    Action

    Kapp Surgical Instrument, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and quarantine any product affected by this recall. The firm will make arrangements for returning the products. Replacements will be made by Kapp Surgical. Questions about this recall are directed to the QA Manager at 800-282-5277.

    Distribution

    Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia.

    Quantity

    222 units (rings)