Encore Medical, Lp: Medical Device Recall in 2017 - (Recall #: Z-1139-2017)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2017.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class II
Date Initiated: January 10, 2017
Date Posted: February 15, 2017
Recall Number: Z-1139-2017
Event ID: 76206
Reason for Recall:
The Empowr PS Insert was reported as missing the impaction slot feature.
Status: Terminated
Product Quantity: 24 units
Code Information:
035U1000
Distribution Pattern:
Nationwide Distribution to CO, NY, and FL
Voluntary or Mandated:
Voluntary: Firm initiated