Device product
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Z-0325-2017
Product summary
- Event
- Event 75214
- Status
- Terminated
- Classification
- Class II
- Quantity
- 436 units
- Official record key
device-enforcement:Z-0325-2017
Official wording
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 information: 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 pattern: US
Derived failure modes
-
Unknown
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.