FDAClass IIDecember 28, 2016

Tibial Component Fixed Hinge Small Long recall

Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the…

Why was Tibial Component Fixed Hinge Small Long 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?

A11290, A10107, A11828, A10610, A10765, A11439, A11922

Product
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the…
Recalling firm
Stanmore Implants Worldwide Ltd.
Quantity
13 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)
Open FDA enforcement record Latest recalls