PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 5, 2017 Initiated: March 8, 2017 #Z-1701-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Biomet 3i, LLC
Units Affected
5
Distribution
Argentina
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product 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". Recalled by Biomet 3i, LLC. Units affected: 5.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1701-2017.