Home / Recalls / Valorem Surgical LLC / Z-2915-2017

Z-2915-2017 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 MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. 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. P765-045; Known Lot No. Unknown, WNV120420, WNV120322, NHS150153, WNV120427, WNV120430.

Other recalls by Valorem Surgical LLC

  • Z-3008-2017 Class II — PALLAS M/MAXIMIS Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixation S (June 21, 2017)
  • Z-2956-2017 Class II — PALLAS M/MAXIMIS 300mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixati (June 21, 2017)
  • Z-3002-2017 Class II — PALLAS M/MAXIMIS Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy (June 21, 2017)
  • Z-2893-2017 Class II — PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation Sys (June 21, 2017)
  • Z-2925-2017 Class II — PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixat (June 21, 2017)
  • Z-2961-2017 Class II — PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Val (June 21, 2017)
  • Z-2923-2017 Class II — PALLAS M/MAXIMIS MIS Screw 5.5 x 45mm & 5.5 x 4.0mm, and 7.5 x 45mm. Part of MAX (June 21, 2017)
  • Z-2968-2017 Class II — PALLAS M/MAXIMIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst (June 21, 2017)
  • Z-2974-2017 Class II — PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal (June 21, 2017)
  • Z-3004-2017 Class II — PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. (June 21, 2017)