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[Recalled] BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile" — A single lot of product that potentially has a single part within the lot th

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductBIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Brand / manufacturerBiomet 3i, LLC
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1701-2017
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date08 March 2017
EAN / barcode00844868009917

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier

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 Biomet 3i, LLC

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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