Reported May 16, 2018 · Terminated
AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide…
Tornier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109
Is this the product you have?
- AEQUALIS HUMERAL NAIL DRILL BIT
- REF 7020140 Product UsageThe 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)
- Lot codes and dates
- Lot numbers
BA0112130BA0114126BA0114174BA0114279BA0114344BA0115022BA0115071BA0115203BA0117059BA0117083BA0117100BA0117145BA0177206BA0215015BA0215022BA0215203BA0312130BA0315203BA0412130BA0415203BA0515203BA0615203
- Lot numbers
- Amount recalled
- 3327 units
Where it was sold
- Nationwide
Why it was recalled
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
This product could cause temporary or reversible health problems — stop using it.
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