Recall Z-0258-2024— Encore Medical, LP

Name: FDA recall Z-0258-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-29

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-09-29. It names one FDA 510(k) clearance: K171991. Product: DJO EMPOWR Knee Punch Handle, REF: 801-05-040. Reason: Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2023-09-29
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K171991 — EMPOWR Porous Knee SystemEncore Medical L.P.·cleared 2017-10-04

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 Knee Punch Handle, REF: 801-05-040

Reason for recall

Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.

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