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Recall Observatory FDA recall evidence

Device 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.

Z-1465-2015

March 12, 2015

Class II

Product summary

Firm
Biomet Spine, LLC
Event
Event 70832
Status
Terminated
Classification
Class II
Quantity
148
Official record key
device-enforcement:Z-1465-2015

Official wording

Reason: 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.

Code information: 538133 ,538134 ,548080 ,550475 ,552169 ,553131, 553710 ,558873 ,567568 ,569141

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.