Home / Recalls / Biomet Spine LLC. / Z-0220-2015

Z-0220-2015 Class II Terminated

Recalled by Biomet Spine LLC. — Broomfield, CO

FDA device recall Z-0220-2015 was initiated by Biomet Spine LLC. on March 9, 2011 and is designated Class II. Reason for recall: Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly. The recall status is terminated (terminated January 7, 2015). Affected quantity: 120.

Recall Details

Product Type
Devices
Report Date
November 26, 2014
Initiation Date
March 9, 2011
Termination Date
January 7, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120

Product Description

LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.

Reason for Recall

Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.

Distribution Pattern

US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,

Code Information

Lot numbers L532655, L532690, Product code 8503XXXX

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-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-0983-2015 Class II — Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timbe (August 22, 2013)
  • Z-0978-2015 Class II — Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Mode (August 22, 2013)

FDA data resources