[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
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System. |
|---|---|
| Brand / manufacturer | DePuy Spine, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0454-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 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.
- The Healthiest Spirituality Options for Modern Life
- Eye Care Safety and Ingredients: What You Need to Know
- Qu'est-ce que 1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters (CAS 68648-93-1) ? Sécurité, réglementation & perspective UE/États-Unis/Canada | ProductGuru
- Best Fiction, Mystery & Detective Books for Vegans
- Was ist 2-[2-(nonylphenoxy)ethoxy]ethanol (CAS 27176-93-8)? Sicherheit, Regulierung & Perspektive EU/USA/Kanada | ProductGuru
- What is the Ice Cream & Frozen Yogurt category? Top brands, safety considerations, EU + US labeling regimes | ProductGuru