FDAFDA · Food and drugs·Recall number 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.
Published April 29, 2015 · Recall initiated: March 12, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet Spine, LLC
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- 538133,538134,548080,550475,552169,553131,553710,558873,567568,569141 Part Number: 6200-1109 2009300344 to 2009300543 2009300544 to 2009300643 2009300644 to 2009300743 2009300744 to 2009300843 2009300844 to 2009300993 2009411328 to 2009411377 2010082160 to 2010082257 2010152507 to 2010152571 2010373025 to 2010373174
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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