Medical device recalls Moderate risk

Biomet 3i, LLC recalls BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit…

Recall date
March 8, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1701-2017
FDA classification
Class II
Brand / firm
Biomet 3i, LLC
Sold / distributed
Argentina

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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