Home / Recalls / Biomet Spine, LLC / Z-1466-2015

Z-1466-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

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
874

Product 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 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 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

Other recalls by Biomet Spine, LLC

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  • 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-1465-2015 Class II — Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct 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)