Recall Z-1465-2015 ยท HXC Wrench
Biomet Spine, LLC
Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.
| Date | Apr 20, 2015 (initiated Mar 12, 2015) |
| Status | Terminated |
| 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 | 148 |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.