C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm… — Class II medical device recall Z-0627-2014
Terminated recall by RTI Surgical, Inc., reported 2014-01-15, distributed nationwide. As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm W
| Recall number | Z-0627-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RTI Surgical, Inc., Marquette, MI, United States |
| Recall initiated | 2013-10-07 |
| Classified | 2014-01-03 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,906 |
| Reason classes | labeling |
| Model numbers | 012-10, 012-11, 30-CW-1, 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0627-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.