Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0627-2014·Announced 2014-01-15

RTI Surgical Recalls C-Plus Implants Due to Labeling Documentation Error

RTI Surgical is recalling 1,906 C-Plus 10mm x 12mm Webless implants because they were incorrectly documented as meeting labeling requirements for a partial Vertebral Body Replacement Device.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the risk scenario (use as a partial VBR) is 'unlikely due to the size of the device,' fitting the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

RTI Surgical, Inc. is recalling 1,906 units of the C-Plus 10mm x 12mm Webless implants. These cervical intervertebral fusion devices are intended to stabilize a cervical spinal segment to promote fusion, restrict motion, and decrease pain. The implants are manufactured from PEEK polymer with tantalum marker pins and are intended for use with supplemental fixation and autograft.

The recall was initiated following an internal review of regulatory documents, which 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). The source text notes that while the use of this device as a partial VBR is unlikely due to its size, such use could result in a specific risk, though the full consequence is not detailed in the provided excerpt.

The affected units were distributed nationwide in the USA, including Florida, Missouri, New York, California, Michigan, and Illinois. The specific part numbers involved are 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9, 30-CW-1012-10, and 30-CW-1012-11. Healthcare providers and patients should contact RTI Surgical for further instructions regarding the return or replacement of these devices.

The recalled product

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…
Manufacturer: RTI Surgical, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
Affected units: 1,906

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

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.

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · RTI Surgical, Inc.

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Same hazard · mis labeling