The Recall Desk
ModerateFDA (Devices)·Z-0454-2016·Announced 2015-12-30

DePuy Spine Recalls Aegis Torque Handles Due to Assembly Defect

DePuy Spine is recalling 16 Aegis Torque Handles because a manufacturing error may prevent them from fully assembling with the tightener shaft.

What this means for you

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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.

Plain-English summary

DePuy Spine, Inc. is recalling 16 Aegis Torque Handles (Catalog No. 2871-10-800) used with the AEGIS Anterior Lumbar Plate System. The recall is due to a manufacturing error that may prohibit some handles from being able to fully assemble with the tightener shaft. Additionally, the design of the inspection gage does not account for the additional shift length.

The affected devices were distributed in the United States to the states of North Carolina, Michigan, Colorado, Maryland, Florida, Idaho, Texas, California, and New York. The specific lot numbers involved are GB0906, GB0707, GB0907, GB58815, GB59244, and GB61134.

Healthcare providers and facilities should check their inventory for these specific catalog and lot numbers. If the recalled devices are found, they should be removed from use and returned to DePuy Spine, Inc. according to the company's instructions.

The recalled product

Product
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Manufacturer
DePuy Spine, Inc.
Affected units
16

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • LOT NUMBER: GB0906 GB0707 GB0907 GB58815 GB59244 GB61134

Distribution

Distributed in 9 states: