FDAClass IIJuly 12, 2017

Medacta GMK HINGE recall

Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

Why was Medacta GMK HINGE recalled?

One lot of product does not include a screw for attachment to the tibial base plate.

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?

Lot # 163646

Product
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Recalling firm
Medacta Usa Inc
Quantity
4 units
Distribution
CA, AZ, NC, Israel, France
Recall date
July 12, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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