FDAClass IIAugust 14, 2019

Geistlich Bio-Oss Pen recall

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage…

Why was Geistlich Bio-Oss Pen recalled?

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

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?

Lots: 81600760, 81700194, 81700829, 81800289, 81800863.

Product
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage…
Recalling firm
Geistlich Pharma North America, Inc.
Quantity
244,268 total
Distribution
US Nationwide distribution.
Recall date
August 14, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls