FDAClass IIDecember 28, 2016

Femoral Shaft L=120mm recall

Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if…

Why was Femoral Shaft L=120mm recalled?

The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

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?

B10191, B10443, B9920, B10561, B9921, B9922

Product
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if…
Recalling firm
Stanmore Implants Worldwide Ltd.
Quantity
11 units
Distribution
Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
Recall date
December 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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