FDAClass IIAugust 14, 2013

Invue Split Driver recall

Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k)…

Why was Invue Split Driver recalled?

Device design.

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?

Lot/Serial Numbers: 027104, 027105

Product
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k)…
Recalling firm
SpineFrontier, Inc.
Quantity
12 devices
Distribution
Nationwide Distribution including Texas, Ohio, and Missouri.
Recall date
August 14, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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