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[Recalled] Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure. — Complaints were received of inconsistencies in the expiration dates shown on th… | F

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductVertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
Brand / manufacturerSynthes USA HQ, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0410-2014
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date30 July 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.

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 Synthes USA HQ, 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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