Device recall

Z-1465-2015: Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage…

FDA device recall · Class II · Biomet Spine, LLC

Key facts

Recall number (Z-number) Z-1465-2015
Recall event 70832
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.
Product code HXC
Recalling firm Biomet Spine, LLC
Recall class Class II
Status Terminated
Termination date Sep 16, 2015
FEI number 3012447612

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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