The Recall Desk

FDA (Devices) recall action 69644

Biomet Microfixation, LLC recalled 14 products on 2014-12-17

The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products
14
Announced
2014-12-17
Critical
0
Units
588

Why these products were recalled

Laser etching on the parts is wider and deeper than the conditions previously validated.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–14 of 14

  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 total temporomandibular joint replacement systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Distribution
    3 states