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.
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-1465-2015
- Quantity
- 148
- 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
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.
More recalls by Biomet Spine Llc.
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230.
Pr...
Feb 12, 2016
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Ante...
Nov 3, 2015
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 an...
Sep 10, 2015