Home / Recalls / Medical Devices
Tornier, Inc recalls AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide
Recalled May 16, 2018 · FDA recall Z-1757-2018 · Tornier
Hazard
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. · FDA Class II
Units
3327 units
Sold at
US Nationwide Distribution
Description
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Product
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).
Manufacturer(s)
Tornier, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →