FDAClass IINovember 19, 2014

GMK Intramedullary Extension Rod 100 mm is a rod to recall

GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment…

Why was GMK Intramedullary Extension Rod 100 mm is a rod to recalled?

Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.

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?

Model Number: 02.07.10.0162

Product
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment…
Recalling firm
Medacta Usa
Quantity
1 rod (US); 145 rods (global)
Distribution
Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
Recall date
November 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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