FDA-Device2018-05-16Class II
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
Tornier, Inc
Hazard
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Sold states
US Nationwide Distribution
Affected count
3327 units
Manufactured in
10801 Nesbitt Ave S, N/A, Bloomington, MN, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1757-2018Don't want to check this manually?
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