Recall Z-1257-2022— Encore Medical, LP

Name: FDA recall Z-1257-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-05

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2022-05-05. It names one FDA 510(k) clearance: K143242. Product: DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708. Reason: A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2022-05-05
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K143242 — Rebel 3DKNEE SystemEncore Medical L.P.·cleared 2015-05-15

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

DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

Reason for recall

A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.

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