Device 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 insert implants are intended to mate with tibial base implants.
Z-1139-2017
Product summary
- Event
- Event 76206
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-1139-2017
Official wording
Reason: The Empowr PS Insert was reported as missing the impaction slot feature.
Code information: 035U1000
Distribution pattern: Nationwide Distribution to CO, NY, and FL
Derived failure modes
-
Unknown
The Empowr PS Insert was reported as missing the impaction slot feature.