FDAClass IIFebruary 15, 2017

Empowr PS Knee Tibial Insert recall

Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial…

Why was Empowr PS Knee Tibial Insert recalled?

The Empowr PS Insert was reported as missing the impaction slot feature.

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?

035U1000

Product
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial…
Recalling firm
Encore Medical, Lp
Quantity
24 units
Distribution
Nationwide Distribution to CO, NY, and FL
Recall date
February 15, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls