Z-1456-2024Class II

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

Name: Z-1456-2024 ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee...
Creator: DePuy Orthopaedics, Inc.
Published: 2024-03-12
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2024-03-12 / Open, Classified / root cause: labeling and UDI

FDA source

DePuy Orthopaedics, Inc. began a recall of ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System on 2024-03-12. FDA classified it as Class II and gives the reason as "Product incorrectly labelled". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1456-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-12
Posted: 2024-03-29
Recalling firm: Depuy Orthopaedics Inc.
Product: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Product incorrectly labelled.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: Consignees were hand-delivered an URGENT MEDICAL DEVICE RECALL REMOVAL notification, dated 3/11/24. The notice instructs consignees to examine their inventory for affected devices and quarantine them, contact their DePuy Synthes Sales Consultant to coordinate return of devices, and return the provided Business Response Form to [email protected]. If product was further distributed forward the provided notice. Forward the notice to anyone in the consignee facility that needs to be informed; the notice should be posted in a visible area for awareness and maintained in consignee records. Questions about this recall should be directed to the consignee's assigned DePuy Synthes Sales Consultant.
Quantity in commerce: 5 units
Distribution: Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
Product codes and lots: Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1456-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1456-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-03-29

Product code MBH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)