FDA recall Z-1456-2024

DePuy Orthopaedics, Inc. · Class II · device

Product

ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.

Reason for recall

Product incorrectly labelled.

Distribution

Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2024-03-12
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1456-2024