AEQUALIS HUMERAL NAIL DRILL BIT — Class II medical device recall Z-1757-2018
Terminated recall by Tornier, Inc, reported 2018-05-16, distributed nationwide. Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
| Recall number | Z-1757-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2018-03-26 |
| Classified | 2018-05-08 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2021-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 3,327 units |
| Reason classes | sterility |
| Lot numbers | BA0112130, BA0114126, BA0114174, BA0114279, BA0114344, BA0115022, BA0115071, BA0115203, BA0117059, BA0117083, BA0117100, BA0117145, BA0177206, BA0215015, BA0215022, BA0215203, BA0312130, BA0315203, BA0412130, BA0415203, BA0515203, BA0615203 |
| Model numbers | 7020140 |
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 for recall
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1757-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.