Recall Z-0766-2025— Encore Medical, LP

Name: FDA recall Z-0766-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-18

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2024-12-18. It names one FDA 510(k) clearance: K143242. Product: EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703. Reason: 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2024-12-18
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

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

Reason for recall

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

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