Home / Recalls / Biomet Spine, LLC / Z-2152-2015

Z-2152-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Parsippany, NJ

Recall Details

Product Type
Devices
Report Date
July 29, 2015
Initiation Date
March 12, 2015
Termination Date
December 21, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,765 units

Product Description

Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.

Reason for Recall

Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.

Distribution Pattern

Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands.

Code Information

Part Numbers: 14-582020, 14-582022, 14-582025, 14-582030, 14-582035, 14-582040, 14-582120, 14-582122, 14-582125, 14-582127, 14-582130, 14-582135, 14-582140, 14-582220, 14-582222, 14-582225, 14-582230, 14-582235, 14-582240, 14-582245, 14-582250, 14-592320, 14-582325, 14-582330, 14-582335, 14-582340, 14-582345, 14-582350, 14-582530, 14-582535, 14-582540, 14-582545, 14-582550, 14-582565, 14-582570, 14-582575, 14-583020, 14-583025, 14-583030, 14-583035, 14-583040, 14-583120, 14-583125, 14-583130, 14-583135, 14-583140, 14-583220, 14-583225, 14-583230, 14-583235, 14-583240, 14-583245, 14-583250, 14-583320, 14-583325, 14-583330, 14-583335, 14-583340, 14-583345 and 14-583350. All lots.

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-1466-2015 Class II — Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage (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)