The Recall Desk

FDA (Devices) recall action 70832

Biomet Spine, LLC recalled 2 products on 2015-04-29

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2015-04-29
Critical
0
Units
1,022

Why these products were recalled

Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.

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.

1–2 of 2

  • ModerateFDA (Devices)··2015-04-29

    Biomet Recalls Lineum HF Torque Handle Limit Due to Component Updates

    Biomet Spine is recalling 148 Lineum HF Torque Handle Limit units because the supplier withdrew the product for component updates or reconfiguration.

    Product
    Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-04-29

    Biomet Recalls Torque Limiting Handles for Spinal Fixation Devices

    Biomet Spine is recalling 874 Torque Limiting Handles used in spinal fixation due to supplier component updates.

    Product
    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
    Category
    Distribution
    0 states