EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in or...
FDA Recall #Z-0328-2018 — Class II — December 12, 2017
Product Description
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
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.
Recalling Firm
Encore Medical, Lp — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 units
Distribution
One medical device distributor in California.
Code Information
Lot 252564
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated