BEUDAMED
    FDA Recall Terminated

    "***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" THIS KIT WAS DISCONTINUED. Kit Contained: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; 60ml syringe; Gauze sponges; Extension tubing; Chloraprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a TMJ arthrocentesis procedure.

    Recall: Z-2849-2011 · Initiated October 8, 2010

    Recall

    Recall Number
    Z-2849-2011
    Event Number
    58980
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    KDD
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    October 8, 2010
    Posted
    July 19, 2011
    Terminated
    April 19, 2012
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    "***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" THIS KIT WAS DISCONTINUED. Kit Contained: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; 60ml syringe; Gauze sponges; Extension tubing; Chloraprep swabsticks; Utility Bowl. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a TMJ arthrocentesis procedure.

    Reason

    Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.

    Action

    Biomet Microfixation (formerly W. Lorenz) sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter to the consignees/customers on October 7, 2010. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to fill out the attached Inventory Reconciliation sheet and fax to 904-741-9425 and if the consignees/customers further distributed this product, they should notify their customers and provide them with a copy of this safety alert (the letter must be given to the personnel responsible for receiving field action notices). If you have any questions, please contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.

    Quantity

    82