Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1466-2015 — Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.

U.S. FDA — Device Enforcement · United States · 2015-03-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1466-2015
Date of alert: 2015-03-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet Spine, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 2009300344

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1466-2015 — Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.

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