FDAClass IIJuly 22, 2015

Altiva / Exactech Spine recall

Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal…

Why was Altiva / Exactech Spine recalled?

Incorrect thread form on the screw.

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?

Catalog Number 28202, Lot Number AS05107

Product
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal…
Recalling firm
Exactech, Inc.
Quantity
749 devices
Distribution
Distributed in the states of FL, GA, IL, NY, TX, and WA.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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