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Recall Observatory FDA recall evidence

Device product

ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003

Z-0631-2022

January 05, 2022

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 89454
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0631-2022

Official wording

Reason: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

Code information: Lots: JH9651, JH9649 GTIN: 10603295383178

Distribution pattern: US Nationwide distribution in the states of TN, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.