Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1757-2018·Announced 2018-05-16

Tornier Aequalis Humeral Nail Drill Bit Recall for Packaging Defect

Tornier is recalling Aequalis Humeral Nail Drill Bits because the tips may puncture sterile packaging, potentially compromising sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a packaging defect that may compromise sterility, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Tornier, Inc. is recalling 3,327 units of Aequalis Humeral Nail Drill Bits (Reference 7020140) distributed nationwide in the United States. The recall involves specific lot numbers listed in the agency record, including BA0112130 and BA0215203.

The recall was initiated because the drill bit tips, which lack the new BargerGard tip protector, may puncture through the sterile packaging. This defect poses a risk to the sterility of the medical device.

Healthcare providers and facilities should stop using the affected drill bits and contact Tornier, Inc. for further instructions on return or replacement. The Aequalis Humeral Nail system is intended for the temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus.

The recalled product

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…
Manufacturer: Tornier, Inc
Category: Medical Device — Orthopedic Instrument
Hazard: packaging-defect
sterility-compromise
Affected units: 3,327

Distribution

Distributed nationwide across the United States.

Same manufacturer · Tornier, Inc

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