BEUDAMED
    FDA Recall Terminated

    PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.

    Recall: Z-2610-2014 · Initiated August 12, 2014

    Recall

    Recall Number
    Z-2610-2014
    Event Number
    69109
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    GAG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 12, 2014
    Posted
    September 8, 2014
    Terminated
    July 10, 2015
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803

    Description

    PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single patient, which is designed to apply rectangular stainless steel staples for routine wound closure.

    Reason

    The device may have a non-conforming component that may cause the device to fire an unformed staple.

    Action

    The firm, Ethicon Endo-Surgery, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 25, 2014 to its customers via overnight, UPS to allow tracking of the receipt. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory to determine if you have recalled product on hand; remove the recalled product and communicate the issue to relevent staff; complete and return Business Reply Form (BRF) confirming receipt of this notice within three (3) business days, indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. The BRF may be sent to Stericycle by fax at 1-855-328-6659 or by email at [email protected]. Product replacement is available for customers who return unopened affected product. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-877-ETHICON (1-877-384-4266). If you need additional shipping labels or a communications package, contact Stericycle at 1-855-328-0398 and reference Event 3022.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and countries of: Armenia, Belgium, Germany, Denmark, Finland, France, UK, Italy, Japan, South Korea, Netherlands, Norway, Russia, Sweden, Singapore, Taiwan, Tanzania, and South Africa.

    Quantity

    42,798