Home / Recalls / Valorem Surgical LLC / Z-2910-2017

Z-2910-2017 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 Polyaxial Screw and MIS Screw, 5.5 x 40mm. 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. P755-040; Known Lot No. Unknown, WNV110513, WNV120322, WNV110511.

Other recalls by Valorem Surgical LLC

  • Z-3002-2017 Class II — PALLAS M/MAXIMIS Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy (June 21, 2017)
  • Z-2977-2017 Class II — PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal (June 21, 2017)
  • Z-2908-2017 Class II — PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fix (June 21, 2017)
  • Z-2929-2017 Class II — PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS Pe (June 21, 2017)
  • Z-2953-2017 Class II — PALLAS M/MAXIMIS 80mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixatio (June 21, 2017)
  • Z-2896-2017 Class II — PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy (June 21, 2017)
  • Z-2945-2017 Class II — PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation (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-2924-2017 Class II — PALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pe (June 21, 2017)
  • Z-2879-2017 Class II — PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fix (June 21, 2017)