FDAClass IINovember 4, 2015

Exprt Precision System: Revision Knee recall: Labeling Error

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the…

Why was Exprt Precision System: Revision Knee recalled?

The labeling is missing the size/diameter information.

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?

471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008

Product
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the…
Recalling firm
Encore Medical, Lp
Quantity
209 units
Distribution
US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
Recall date
November 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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