Z-0627-2014Class II

C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical...

Name: Z-0627-2014 C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical...
Creator: RTI Surgical, Inc.
Published: 2013-10-07
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2013-10-07 / Terminated / root cause: labeling and UDI

FDA source

RTI Surgical, Inc. began a recall of 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... on 2013-10-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0627-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Posted: 2014-01-03
Terminated: 2014-02-26
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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.
Product code: ODP Intervertebral Fusion Device With Bone Graft, Cervical
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
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
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.
Quantity in commerce: 1906
Distribution: Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0627-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0627-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-03

Product code ODP

K073177Class IIPioneer Intervertebral Fusion Device SystemPioneer Surgical Technology / cleared 2008-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)