Home / Recalls / Biomet Spine, LLC / Z-1465-2015

Z-1465-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

FDA device recall Z-1465-2015 was initiated by Biomet Spine, LLC on March 12, 2015 and is designated Class II. 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. The recall status is terminated (terminated September 16, 2015). Affected quantity: 148.

Recall Details

Product Type
Devices
Report Date
April 29, 2015
Initiation Date
March 12, 2015
Termination Date
September 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
148

Product Description

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.

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 Pattern

Worldwide Distribution - US Nationwide

Code Information

538133 ,538134 ,548080 ,550475 ,552169 ,553131, 553710 ,558873 ,567568 ,569141

Other recalls by Biomet Spine, LLC

  • Z-1253-2016 Class II — 10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model (February 12, 2016)
  • Z-0203-2016 Class II — MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate Sy (September 29, 2015)
  • Z-2744-2015 Class II — Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervic (August 5, 2015)
  • Z-2759-2015 Class II — Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model (July 22, 2015)
  • Z-2152-2015 Class II — Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial S (March 12, 2015)
  • Z-1466-2015 Class II — Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage (March 12, 2015)
  • Z-0982-2015 Class II — Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630- (August 22, 2013)
  • Z-0978-2015 Class II — Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Mode (August 22, 2013)
  • Z-0983-2015 Class II — Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timbe (August 22, 2013)
  • Z-1146-2015 Class II — Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy se (November 30, 2012)

FDA data resources