Home / Recalls / Valorem Surgical LLC / Z-2891-2017

Z-2891-2017 Class II Terminated

Recalled by Valorem Surgical LLC — Chicago, IL

Recall Details

Product Type
Devices
Report Date
August 16, 2017
Initiation Date
June 21, 2017
Termination Date
November 27, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,225 units total

Product Description

PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Reason for Recall

Devices are not consistent with Quality System Requirements.

Distribution Pattern

Nationwide Distribution - US including CA and VA.

Code Information

Catalog No. MR58-035; Known Lot No. NHS150611 & WNV120323.

Other recalls by Valorem Surgical LLC

  • Z-2944-2017 Class II — PALLAS M/MAXIMIS 60mm Curved and Precontoured Rod. Part of MAXIMIS Pedicle Screw (June 21, 2017)
  • Z-2978-2017 Class II — PALLAS M/MAXIMIS Dilator Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation S (June 21, 2017)
  • Z-2914-2017 Class II — PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixa (June 21, 2017)
  • Z-2949-2017 Class II — PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixatio (June 21, 2017)
  • Z-2983-2017 Class II — PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation (June 21, 2017)
  • Z-3013-2017 Class II — PALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation System (June 21, 2017)
  • Z-2982-2017 Class II — PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation (June 21, 2017)
  • Z-2905-2017 Class II — PALLAS M/MAXIMIS Poly Screw 7.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fix (June 21, 2017)
  • Z-2876-2017 Class II — PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixatio (June 21, 2017)
  • Z-3005-2017 Class II — PALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation (June 21, 2017)