medical MODERATE Updated 2017-04-05

Biomet 3i, LLC recalls BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Pla

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Recalled Product

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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Hazard / Issue

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

Issued by

FDA

Distribution: Argentina
Lot/Code Info: LTX610, lot 1199571; UDI: (01)00844868009917(17)210916(10)1199571

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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