FDAClass IISeptember 18, 2013

StaXx¿ IB Convex Expandable Implant recall

StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body…

Why was StaXx¿ IB Convex Expandable Implant recalled?

A component Superior endplate manufactured from a different polymer than specified

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 Numbers: 272L08 and 272L09

Product
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body…
Recalling firm
Spine Wave, Inc.
Quantity
17 units
Distribution
Distributed in the states of FL and OR.
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls