ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen
Summary
The FDA issued a Class II for ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Compo by DePuy Orthopaedics, Inc.. Reason: Product incorrectly labelled..
Details
Source
Device Recall
External ID
Z-1456-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Lot/Code Info: Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.
Quantity Affected: 5 units
Reason for Recall
Product incorrectly labelled.
Distribution
Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-12
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DePuy Orthopaedics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DePuy Orthopaedics, Inc. have FDA actions?
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1456-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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