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DePuy Orthopaedics, Inc. Recall 89454

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

DePuy Orthopaedics, Inc. Recall 89454 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0631-2022
Event ID89454
Event DescriptionATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
Product TypeDevices
DistributionUS Nationwide distribution in the states of TN, TX.
Quantity6 units
Recall ReasonMay have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Device Classification20220216
Device Code InfoLots: JH9651, JH9649 GTIN: 10603295383178
Center Classification Date20220209
Recall Initiation Date20220105
Recalling FirmDePuy Orthopaedics, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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