Z-1701-2017 Class II Terminated
FDA device recall Z-1701-2017 was initiated by Biomet 3i, LLC on March 8, 2017 and is designated Class II. 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 The recall status is terminated (terminated August 2, 2019). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- March 8, 2017
- Termination Date
- August 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
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
Distribution Pattern
Argentina
Code Information
LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571