Recall Z-0165-2016— Encore Medical, Lp

Name: FDA recall Z-0165-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-16

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2015-09-16, terminated 2016-01-04. It names one FDA 510(k) clearance: K140830. Product: Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.. Reason: The labeling is missing the size/diameter information..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2015-09-16
Terminated: 2016-01-04
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K140830 — EXPRT REVISION KNEEEncore Medical L.P.·cleared 2014-07-11

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

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

Reason for recall

The labeling is missing the size/diameter information.

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