FDA Recall Terminated

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.

Recall: Z-0627-2014 · Initiated October 7, 2013

Recall

Recall Number: Z-0627-2014
Event Number: 67093
Firm: RTI Surgical, Inc.
FEI Number: 1000115331
Product Code: ODP
Status: Terminated
Root Cause: Labeling False and Misleading
Initiated: October 7, 2013
Posted: January 3, 2014
Terminated: February 26, 2014
Address: 375 River Park Cir, Marquette, MI, 49855-1781

Description

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

Action

RTI Surgical, Inc. sent an Important Notice letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed remove fall affected product from their inventory and send back to Customers Service at 375 River Park Circle, Marquette, MI 49855 by October 16, 2013. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.

Distribution

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

Quantity

1906