RTI Surgical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0627-2014)

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:

C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.

Product Classification:

Class II

Date Initiated: October 7, 2013

Date Posted: January 15, 2014

Recall Number: Z-0627-2014

Event ID: 67093

Reason for Recall:

As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s

Status: Terminated

Product Quantity: 1906

Code Information:

part numbers: 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9, 30-CW-1 012-10, 30-CW-1 012-11.

Distribution Pattern:

Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.

Voluntary or Mandated:

Voluntary: Firm initiated