FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
- Recall number
- Z-1456-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2024-03-12
- Posted
- 2024-03-29
- Terminated
- not on file
- Reason
- Product incorrectly labelled.
- 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 OneMD-Field-Actions@its.jnj.com. 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
- 5 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
- Lot, serial or model codes
- Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.
- 510(k) numbers
- ["K202194","K213781","K232303"]
- PMA numbers
- not on file
- Product code
- MBH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28