Tornier, Inc recalls AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide tem…

Recall date

March 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1757-2018

FDA classification

Class II

Brand / firm

Tornier, Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).