Home / Recalls / Spinal Elements, Inc / Z-1250-2013

Z-1250-2013 Class III Terminated

Recalled by Spinal Elements, Inc — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
May 15, 2013
Initiation Date
April 17, 2009
Termination Date
May 7, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
68 units total

Product Description

Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Reason for Recall

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Distribution Pattern

Distributed in OH and PA.

Code Information

Lot number: 080586

Other recalls by Spinal Elements, Inc

  • Z-1912-2018 Class II — AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 T (April 16, 2018)
  • Z-1597-2015 Class III — Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spi (April 9, 2015)
  • Z-0907-2015 Class II — Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This devic (December 18, 2014)
  • Z-1259-2013 Class III — Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. I (April 17, 2009)
  • Z-1256-2013 Class III — Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. I (April 17, 2009)
  • Z-1262-2013 Class III — Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. I (April 17, 2009)
  • Z-1263-2013 Class III — Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. (April 17, 2009)
  • Z-1253-2013 Class III — Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. (April 17, 2009)
  • Z-1258-2013 Class III — Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. I (April 17, 2009)
  • Z-1264-2013 Class III — Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. (April 17, 2009)