X Spine Systems Inc: Medical Device Recall in 2014 - (Recall #: Z-2136-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 11, 2014

Date Posted: August 13, 2014

Recall Number: Z-2136-2014

Event ID: 68863

Reason for Recall:

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

Status: Terminated

Product Quantity: A total of 5-pieces of each part number distributed

Code Information:

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

Distribution Pattern:

US Distribution including the states of FL and MO.

Voluntary or Mandated:

Voluntary: Firm initiated