BEUDAMED
    FDA Recall Terminated

    Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

    Recall: Z-2811-2015 · Initiated August 31, 2015

    Recall

    Recall Number
    Z-2811-2015
    Event Number
    72139
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    GXN
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 31, 2015
    Posted
    September 23, 2015
    Terminated
    August 18, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

    Reason

    The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe.

    Action

    DePuy Synthes sent an URGENT:FIELD SAFETY NOTIFICATION / MEDICAL DEVICE LABELING CORRECTION letter, dated August 31, 2015 to affected customers. The letter identified affected product, problem and actions to be taken. Customers were instructed to: "Update and review the package insert (GP1345-D). " Discard outdated package insert noted in the table above. " Forward this Field Safety Notification to anyone in your facility that needs to be informed, especially personnel that conduct MR testing. " If the package insert has been forwarded to another facility, contact that facility. " Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section by, Fax: 877-884-7821 or Scan/email: [email protected] " If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. " Maintain a copy of this notice. For questions call 610-719-5450.

    Distribution

    US Nationwide and internationally, including Canada.

    Quantity

    105882