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Recall Observatory FDA recall evidence

Device product

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

Z-1456-2024

March 12, 2024

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 94222
Status
Ongoing
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1456-2024

Official wording

Reason: Product incorrectly labelled.

Code information: Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product incorrectly labelled.