Z-1757-2018 Class II Terminated
FDA device recall Z-1757-2018 was initiated by Tornier, Inc on Mar 26, 2018 and is designated Class II. Reason for recall: Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. The recall status is terminated (terminated Aug 12, 2021). Affected quantity: 3327 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 26, 2018
- Termination Date
- Aug 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3327 units
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).
Reason for Recall
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Distribution Pattern
US Nationwide Distribution
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1757-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026