FDA Medical Device Recalls (openFDA)
Biomet Spine, LLC: 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 number
- Z-1466-2015
- Recalling firm
- Biomet Spine, LLC
- Product
- Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
- Status
- Terminated
- Initiated
- 2015-03-12
- Posted
- 2015-04-20
- Terminated
- 2015-09-16
- 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.
- Root cause
- Component design/selection
- 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.
- Quantity
- 874
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXC
- Firm FEI
- 3012447612
- Firm city
- Broomfield
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28