BEUDAMED
    FDA Recall Terminated

    TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies

    Recall: Z-2240-2016 · Initiated June 10, 2016

    Recall

    Recall Number
    Z-2240-2016
    Event Number
    74576
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 10, 2016
    Posted
    July 19, 2016
    Terminated
    July 20, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies

    Reason

    The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 10, 2016, to all affected customers via courier. Distributors and hospitals were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-6725, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan

    Quantity

    5458 units