FDA Recall
Terminated
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
Recall: Z-1466-2015
·
Initiated March 12, 2015
Recall
- Recall Number
- Z-1466-2015
- Event Number
- 70832
- Firm
- Biomet Spine, LLC
- FEI Number
- 3012447612
- Product Code
- HXC
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- March 12, 2015
- Posted
- April 20, 2015
- Terminated
- September 16, 2015
- Address
- 310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464
Description
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
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.
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.
Distribution
Worldwide Distribution - US Nationwide
Quantity
874