Recall Z-0627-2014— RTI Surgical, Inc.

Name: FDA recall Z-0627-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-07

Class II · Terminated

Class II FDA medical device recall by RTI Surgical, Inc., initiated 2013-10-07, terminated 2014-02-26. It names one FDA 510(k) clearance: K073177. Product: 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.. Reason: 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.

Recalling firm: RTI Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Terminated: 2014-02-26
Firm location: Marquette, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K073177 — PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEMPioneer Surgical Technology·cleared 2008-05-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.