Recall Z-1213-2013— Encore Medical, Lp

Name: FDA recall Z-1213-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-01

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2013-04-01, terminated 2013-07-01. It names one FDA 510(k) clearance: K091956. Product: 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.. Reason: U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2013-04-01
Terminated: 2013-07-01
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K091956 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712Encore Medical L.P.·cleared 2010-09-28

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

3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

Reason for recall

U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.

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