Home / Recalls / X Spine Systems Inc / Z-2136-2014

Z-2136-2014 Class II Terminated

Recalled by X Spine Systems Inc — Miamisburg, OH

Recall Details

Product Type
Devices
Report Date
August 13, 2014
Initiation Date
July 11, 2014
Termination Date
August 14, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
A total of 5-pieces of each part number distributed

Product Description

Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.

Reason for Recall

Revision B of the tissue shields of the device was 7 mm longer than the previous design.

Distribution Pattern

US Distribution including the states of FL and MO.

Code Information

Part numbers X079-0096 and X079-0097 with Lot #12320

Other recalls by X Spine Systems Inc

  • Z-0127-2017 Class II — Calix T PEEK Lumbar System, TLIF Trial (May 17, 2016)
  • Z-0125-2017 Class II — Calix P PEEK Lumbar System, PLIF Trial (May 17, 2016)
  • Z-0126-2017 Class II — Calix T PEEK Lumbar System, TLIF Rasp (May 17, 2016)
  • Z-0124-2017 Class II — Calix P PEEK Lumbar System, PLIF Rasp (May 17, 2016)
  • Z-1823-2015 Class II — Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, (April 7, 2015)
  • Z-1512-2015 Class II — Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device (March 11, 2015)