C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's recall: Labeling Error
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are…
Why was C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- RTI Surgical, Inc.
- Quantity
- 1906
- Distribution
- Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.
- Recall date
- January 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)