Reported Jan 15, 2014 · Terminated
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical…
RTI Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RTI Surgical, Inc. · 375 River Park Cir · Marquette, MI · 49855-1781
Is this the product you have?
- 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.
- Lot codes and dates
- part numbers
30-CW-1012-530-CW-1012-630-CW-1012-730-CW-1012-830-CW-1012-930-CW-1 012-1030-CW-1 012-11
- part numbers
- Amount recalled
- 1906
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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