BEUDAMED
    FDA Recall Terminated

    ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIST DRILL D2,0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0

    Recall: Z-0620-2018 · Initiated September 5, 2017

    Recall

    Recall Number
    Z-0620-2018
    Event Number
    79068
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    September 5, 2017
    Terminated
    September 20, 2019
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIST DRILL D2,0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0

    Reason

    ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

    Action

    Notifications were sent requesting the customers immediately discontinue use and quarantine affected products. The notification explains that a sales representative will visit the facilities to remove affected product and return it to the firm.

    Distribution

    Distributed to 4 hospitals in the following states: NM, OH, TX, WV

    Quantity

    6211