FDAFDA · Food and drugs·Recall number Z-1701-2017
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Published April 5, 2017 · Recall initiated: March 8, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- Argentina
- Lot
- LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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