Recall Z-0102-2024— Encore Medical, LP

Name: FDA recall Z-0102-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-22

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-08-22. It names one FDA 510(k) clearance: K143242. Product: EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705. Reason: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee)..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2023-08-22
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, 10MM, VE, REF: 342-10-705

Reason for recall

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

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