FDA Recall
Terminated
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Recall: Z-0325-2017
·
Initiated September 19, 2016
Recall
- Recall Number
- Z-0325-2017
- Event Number
- 75214
- FEI Number
- 1000116912
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- September 19, 2016
- Terminated
- October 20, 2017
- Address
- 9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445
Description
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Reason
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.
Action
The recalling firm sent a recall notification letter to affected consignees on 9/19/16. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device.
Distribution
US
Quantity
436 units