FDAClass IIApril 5, 2017

Biomet 3i LTX Dental Implants recall

BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"

Why was Biomet 3i LTX Dental Implants recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571

Product
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Recalling firm
Biomet 3i, LLC
Quantity
5
Distribution
Argentina
Recall date
April 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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