FDAClass IISeptember 23, 2015

Aliquot Delivery Kit recall

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or…

Why was Aliquot Delivery Kit recalled?

Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

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?

All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Product
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or…
Recalling firm
Orthovita, Inc., dBA Stryker Orthobiologics.
Quantity
9805
Distribution
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Recall date
September 23, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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