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Terminated

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.

FDA Recall Z-1465-2015 · Posted 2015-04-20

Recalling FirmBiomet Spine, LLC
Recall StatusTerminated
Product CodeHXC
Date Initiated2015-03-12
Date Terminated2015-09-16
Product Quantity148

Reason for Recall

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.

Firm Action

Biomet sent an Urgent Medical Device Recall Notice dated March 12, 2015 via phone and customer letters. The letter identified the affected product, problem and actions to be taken. Customers were asked to follow the instructions on the enclosed "Response Form". For questions call 858-232-2672.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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