Devices

Device Recall AEQUALIS HUMERAL NAIL DRILL BIT

Model / Serial
Lot numbers: BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
US Nationwide Distribution
Product 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).
Manufacturer
Tornier, Inc
1 Event
- Recall of Device Recall AEQUALIS HUMERAL NAIL DRILL BIT

Manufacturer

Tornier, Inc

Manufacturer Address
Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
Manufacturer Parent Company (2017)
Wright Medical Group NV
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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