Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
This recall has been terminated (originally issued April 20, 2015).
- Company
- Biomet Spine Llc.
- Recall Initiated
- March 12, 2015
- Posted
- April 20, 2015
- Terminated
- September 16, 2015
- Recall Number
- Z-1466-2015
- Quantity
- 874
- Firm Location
- Broomfield, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US Nationwide
Lot / Code Info
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
Root Cause
Component design/selection
Action Taken
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.