Home / Recalls / Biomet Spine, LLC / Z-0203-2016

Z-0203-2016 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

Recall Details

Product Type
Devices
Report Date
November 11, 2015
Initiation Date
September 29, 2015
Termination Date
April 29, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 units

Product Description

MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.

Reason for Recall

The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.

Distribution Pattern

US Distribution to the states of : NY, MO, and FL

Code Information

P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550

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-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-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)