Encore Medical, Lp: Medical Device Recall in 2018 - (Recall #: Z-0328-2018)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
Product Description:
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
Product Classification:
Class II
Date Initiated: December 12, 2017
Date Posted: January 17, 2018
Recall Number: Z-0328-2018
Event ID: 78727
Reason for Recall:
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Status: Terminated
Product Quantity: 2 units
Code Information:
Lot 252564
Distribution Pattern:
One medical device distributor in California.
Voluntary or Mandated:
Voluntary: Firm initiated