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.
FDA Recall Z-0627-2014 · Posted 2014-01-03
Recalling FirmRTI Surgical, Inc.
Recall StatusTerminated
Product CodeODP
Date Initiated2013-10-07
Date Terminated2014-02-26
Product Quantity1906
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
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.