FDA Enforcement
Class II
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
·
Reported November 9, 2016
Enforcement
- Recall Number
- Z-0325-2017
- Event ID
- 75214
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Encore Medical, Lp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 9, 2016
- Initiation Date
- September 19, 2016
- Classification Date
- October 28, 2016
- Termination Date
- October 20, 2017
- Address
- 9800 Metric Blvd, Austin, TX, 78758-5445, United States
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.
Code Info
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
Distribution
US
Quantity
436 units