FDA Device recall Z-1757-2018
AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization…
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization… by Tornier, citing drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1757-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-26 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tornier |
| Distribution | US |
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).
Reason
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Identifiers
| code_info | Lot numbers: BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA011…Lot numbers: BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1757-2018%22
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