FDA recall Z-0258-2024

Encore Medical, LP · Class II · device

Product

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.

Distribution

US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA

Key facts

Status
Ongoing
Initiation date
2023-09-29
Report date
2023-11-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0258-2024