CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Aequalis Humeral Nail Drill Bit recalled by Tornier
Tornier is recalling Aequalis Humeral Nail Drill Bit, distributed nationwide in the US. The recall was initiated on 26 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1757-2018
- FDA event ID
- 79907
- Recalling firm
- Tornier, Bloomington, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2018
- FDA classified
- 8 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 26 Mar 2018 | Recall initiated by company | |
| 8 May 2018 | Classified by FDA | +43 days |
| 16 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Which lots are affected?
Lot numbers: BA0112130 BA0114126 BA0114174 BA0114279 BA0114344 BA0115022 BA0115071 BA0115203 BA0117059 BA0117083 BA0117100 BA0117145 BA0177206 BA0215015 BA0215022 BA0215203 BA0312130 BA0315203 BA0412130 BA0415203 BA0515203 BA0615203
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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