FDAClass IIDecember 26, 2012

EBI XFIX DFS Rail System recall

EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw…

Why was EBI XFIX DFS Rail System recalled?

It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.

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 06350 and Lot Number Identification 994790 (packaged as 042210)

Product
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw…
Recalling firm
Biomet, Inc.
Quantity
49
Distribution
Worldwide Distribution, including the states of TX, TN, PA, CA, NY, FL, and MI and the countries of Japan and Columbia.
Recall date
December 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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