BEUDAMED
    FDA Enforcement Class II 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 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1757-2018
    Event ID
    79907
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tornier, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 16, 2018
    Initiation Date
    March 26, 2018
    Classification Date
    May 8, 2018
    Termination Date
    August 12, 2021
    Address
    10801 Nesbitt Ave S, N/A, Bloomington, MN, 55437-3109, United States

    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.

    Code Info

    Lot numbers: BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203

    Distribution

    US Nationwide Distribution

    Quantity

    3327 units