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[Recalled] Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System. — Manufacturing error within the Torque Handle may prohibit some handles from bei… | FDA 2015-11-20

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductAegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Brand / manufacturerDePuy Spine, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0454-2016
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date20 November 2015

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from DePuy Spine, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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