Device 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).
Z-1757-2018
Product summary
- Firm
- Tornier, Inc
- Event
- Event 79907
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3327 units
- Official record key
device-enforcement:Z-1757-2018
Official wording
Reason: Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Code information: Lot numbers: BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.