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

FDA device recall Z-0627-2014 · posted 2014-01-03 · Terminated

Recall details

Recalling firm

RTI Surgical, Inc.

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

Action taken

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

Status

Terminated

Product code

ODP

Quantity affected

1906

Distribution

Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.

Date initiated

2013-10-07

Date posted

2014-01-03

Date terminated

2014-02-26

Location

Marquette, MI

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