FDAClass IIJanuary 1, 2014

PedFuse Reset Screw Inserters recall

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond…

Why was PedFuse Reset Screw Inserters recalled?

Screw inserters may not mate properly with hex interface of the screws.

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?

VM13221-34457

Product
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond…
Recalling firm
SpineFrontier, Inc.
Quantity
4
Distribution
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Recall date
January 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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