Home / Recalls / Spinal Solutions, LLC / Z-1416-2013

Z-1416-2013 Class II Terminated

Recalled by Spinal Solutions, LLC — Murrieta, CA

Recall Details

Product Type
Devices
Report Date
June 5, 2013
Initiation Date
February 20, 2013
Termination Date
March 26, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35 units

Product Description

14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

Reason for Recall

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Distribution Pattern

USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.

Code Information

Item # 21411-706 21411-707 21411-708 21411-709 21411-710 21411-711 21411-712

Other recalls by Spinal Solutions, LLC

  • Z-1157-2013 Class II — APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumb (March 8, 2013)
  • Z-1415-2013 Class II — 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm (February 20, 2013)
  • Z-1413-2013 Class II — 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variet (February 20, 2013)
  • Z-1418-2013 Class II — Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distribute (February 20, 2013)
  • Z-1417-2013 Class II — Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copp (February 20, 2013)
  • Z-1412-2013 Class II — 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variet (February 20, 2013)
  • Z-1409-2013 Class II — 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a vari (February 20, 2013)
  • Z-1414-2013 Class II — 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variet (February 20, 2013)
  • Z-1410-2013 Class II — 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a vari (February 20, 2013)
  • Z-1411-2013 Class II — Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variet (February 20, 2013)