FDAClass IIMay 21, 2014

PS-C Femoral Nonporous Rt Sz 6 recall

PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee…

Why was PS-C Femoral Nonporous Rt Sz 6 recalled?

A femoral component containing pegs was found in a box for the pegless version.

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 No. A131876

Product
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee…
Recalling firm
Ortho Development Corporation
Quantity
5
Distribution
US Nationwide Distribution in the states of NV, and AZ.
Recall date
May 21, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls