BEUDAMED
    FDA Recall Terminated

    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

    Recall: Z-0391-2016 · Initiated October 30, 2015

    Recall

    Recall Number
    Z-0391-2016
    Event Number
    72598
    Firm
    BioHorizons Implant Systems Inc
    FEI Number
    1000592496
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 30, 2015
    Posted
    December 7, 2015
    Terminated
    February 4, 2016
    Address
    2300 Riverchase Ctr, Hoover, AL, 35244-2808

    Description

    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

    Reason

    An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.

    Action

    BioHorizons sent an Urgent Medical Device Field Correcton letter dated Friday, October 30, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete the enclosed Customer Reply Form and fax to 205-484-2195 or scan to PDF and e-mail to [email protected]. The sole international consignee was notified Monday, 02 November 2015. Customers with questions were instructed to contact the Customer Care Department at 888-246-8338. For questionsn regarding this recall call 205-986-1205.

    Distribution

    Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.

    Quantity

    32 units