BEUDAMED
    FDA Recall Terminated

    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

    Recall: Z-0163-2013 · Initiated July 5, 2012

    Recall

    Recall Number
    Z-0163-2013
    Event Number
    63272
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 5, 2012
    Posted
    October 29, 2012
    Terminated
    January 28, 2013
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

    Reason

    Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.

    Action

    Stryker Spine sent an Urgent Medical Device Field Correction Notification letter beginning July 5, 2012, to all affected customers. Teh letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the drill bit length in each respective drill guide prior to surgery to ensure the correct length protrudes through the guide. Customers with questions should call 201-760-8298. Customers were asked to report any adverse events or product quality problems to 1-888-457-7463.

    Distribution

    Nationwide distribution.

    Quantity

    6154 units