Device product

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

Z-1701-2017

March 08, 2017

Class II

Product summary

Firm: Biomet 3i, LLC
Event: Event 76809
Status: Terminated
Classification: Class II
Quantity: 5
Official record key: device-enforcement:Z-1701-2017

Official wording

Reason: 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

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

Distribution pattern: Argentina

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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