Recall Z-0329-2018— Encore Medical, Lp

Name: FDA recall Z-0329-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-12

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2017-12-12, terminated 2022-06-13. It names one FDA 510(k) clearance: K100900. Product: EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.. Reason: 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
Classification: Class II
Status: Terminated
Initiated: 2017-12-12
Terminated: 2022-06-13
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K100900 — MOTIVATION KNEE SYSTEMEncore Medical L.P.·cleared 2010-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.