BEUDAMED
    FDA Recall Terminated

    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.

    Recall: Z-1915-2015 · Initiated May 27, 2015

    Recall

    Recall Number
    Z-1915-2015
    Event Number
    71361
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 27, 2015
    Posted
    June 26, 2015
    Terminated
    December 18, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.

    Reason

    certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).

    Action

    DePuy Synthes sent an Urgent Medical Device Safety Notification, dated May 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Required: Please take the following actions: Review the information listed in this notification. Forward this notice to anyone in your facility that needs to be informed. 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: (888) 912-2182 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. If you have any questions, please call (610)719-5450. Thank you for your attention to this issue.

    Distribution

    Nationwide Distribution.

    Quantity

    276