Z-1757-2018Class II

Aequalis Humeral Nail Drill Bit, Ref 7020140

Name: Z-1757-2018 Aequalis Humeral Nail Drill Bit, Ref 7020140
Creator: Tornier, Inc
Published: 2018-03-26
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2018-03-26 / Terminated / root cause: packaging

FDA source

Tornier, Inc began a recall of AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of... on 2018-03-26. FDA classified it as Class II and gives the reason as "Drill bit tips without new BargerGard tip protector may puncture through sterile packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1757-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Posted: 2018-05-09
Terminated: 2021-08-12
Recalling firm: TORNIER Inc.
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).
Product code: HTW Bit, Drill
Reason for recall: Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: The firm contacted its distributors by email on 26-March-2018, and a written letter sent 27-March-2018 via FedEx. The Medical Facility was contacted with a written letter sent 28-March-2018 via FedEx.. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the attached Acknowledgement to Wright Medical via email to [email protected]. For questions call 952-683-7482.
Quantity in commerce: 3327 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot numbers: BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1757-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1757-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08

Product code HTW

K082754Class IIAequalis Humeral Nail SystemTornier / cleared 2009-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)