BEUDAMED
    FDA Recall Terminated

    Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo

    Recall: Z-1821-2013 · Initiated October 12, 2012

    Recall

    Recall Number
    Z-1821-2013
    Event Number
    65668
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    October 12, 2012
    Posted
    July 29, 2013
    Terminated
    June 11, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo

    Reason

    A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. The firm identified that this constituted a field action and retrospectively reported this action.

    Action

    The firm, Synthes USA, sent an email to its customer. The email identified the product, problem and the actions to be taken. The customer was instructed to do the following: do not use this product; do not remove any product from your account or return any product without further instructions. If you have identified that you have the product, please have the product located in an area that ensures it will not be used. Further instructions will be sent out with regards to any action that needs to be taken next. Please call Synthes if you have any questions at 610-719-5364.

    Distribution

    US distribution: PA only. .

    Quantity

    2