FDAClass IIJuly 2, 2014

Integra UCR 3mm Hex recall

Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying…

Why was Integra UCR 3mm Hex recalled?

Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use.

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?

Catalogue Number: 91- 1123. Lot No. M016090B.

Product
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying…
Recalling firm
SeaSpine Inc
Quantity
7
Distribution
US Distribution including the states of : AL, CA, OH, NM and TN.
Recall date
July 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls