RecallRadar

FDA Device recall Z-1456-2024

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

On 2024-04-10 the FDA classified a Class II recall of ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System by Depuy Orthopaedics, citing product incorrectly labelled.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1456-2024
ClassificationClass II
Statusongoing
Initiated2024-03-12
Published2024-04-10
Last updated2026-09-13 11:57 UTC
CompanyDepuy Orthopaedics
DistributionUS

Product

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

Reason

Product incorrectly labelled.

Identifiers

code_infoModel No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1456-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.