FDA recall Z-1225-2022

MicroPort Orthopedics Inc. · Class II · device

Product

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

Reason for recall

One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.

Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.

Key facts

Status
Terminated
Initiation date
2022-05-04
Report date
2022-06-08
Termination date
2024-01-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arlington, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1225-2022