Recall Z-1757-2018— Tornier, Inc

Name: FDA recall Z-1757-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-26

Class II · Terminated

Class II FDA medical device recall by Tornier, Inc, initiated 2018-03-26, terminated 2021-08-12. It names one FDA 510(k) clearance: K082754. 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..

Recalling firm: Tornier, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Terminated: 2021-08-12
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K082754 — AEQUALIS HUMERAL NAIL SYSTEMTornier·cleared 2009-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.