BEUDAMED
    FDA Recall Terminated

    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

    Recall: Z-1757-2018 · Initiated March 26, 2018

    Recall

    Recall Number
    Z-1757-2018
    Event Number
    79907
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    March 26, 2018
    Terminated
    August 12, 2021
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    Description

    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

    Reason

    Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.

    Action

    The firm contacted its distributors by email on 26-March-2018, and a written letter sent 27-March-2018 via FedEx. The Medical Facility was contacted with a written letter sent 28-March-2018 via FedEx.. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the attached Acknowledgement to Wright Medical via email to [email protected]. For questions call 952-683-7482.

    Distribution

    US Nationwide Distribution

    Quantity

    3327 units