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[Recalled] Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throa

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

ProductStryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxill
Brand / manufacturerStryker Instruments Div. of Stryker Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1761-2014
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date22 May 2014
EAN / barcode14009017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

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 Stryker Instruments Div. of Stryker Corporation

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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