FDAClass IIDecember 21, 2016

Empowr PS Knee System Box Cut Guide The EMPOWER PS Box recall

Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized…

Why was Empowr PS Knee System Box Cut Guide The EMPOWER PS Box recalled?

It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.

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?

202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, 203203L01

Product
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized…
Recalling firm
Encore Medical, Lp
Quantity
162 units
Distribution
Nationwide Distribution
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls