Empowr PS Knee System Box Cut Guide recall
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Why was Empowr PS Knee System Box Cut Guide 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. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
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, 202434L01, 203779L01, 202351L02, 202434L02, 202351L03, 202434L03, 203779L03, 202351L04, 202434L04, 202351L05, 202434L05, 202351L06, 202434L06, 203779L06, 202351L07, 202434L07, 203779L07, 202351L08, 202434L08, 203779L08, 202351L09, 202434L09, 202351L10, 202434L10, 203203L01
- Product
- Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
- Recalling firm
- Encore Medical, Lp
- Quantity
- 436 units
- Distribution
- US
- Recall date
- November 9, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)