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Open, Classified

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

FDA Recall Z-1456-2024 · Posted 2024-03-29

Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusOpen, Classified
Product CodeMBH
Date Initiated2024-03-12
Product Quantity5 units

Reason for Recall

Product incorrectly labelled.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyDepuy Ireland UC · 2023-12-11K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC · 2022-01-18K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyDepuy Ireland UC · 2020-11-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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