FDA Enforcement
Class II
Ongoing
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Recall: Z-1456-2024
·
Reported April 10, 2024
Enforcement
- Recall Number
- Z-1456-2024
- Event ID
- 94222
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DePuy Orthopaedics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- April 10, 2024
- Initiation Date
- March 12, 2024
- Classification Date
- March 29, 2024
- Address
- 700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States
Description
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Reason
Product incorrectly labelled.
Code Info
Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.
Distribution
Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
Quantity
5 units