The Recall Desk
HighFDA (Devices)·Z-0631-2022·Announced 2022-02-16

Knee Replacement Component Recalled for Adhesive Residue Risk

DePuy Orthopaedics is recalling ATTUNE Revision knee implant components due to possible adhesive residue on the surface. If undetected before surgery, the residue may cause soft tissue irritation or infection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical knee implant component with potential for soft tissue irritation and infection if adhesive residue is not detected and removed before implantation. No illnesses or injuries have been reported to date, making this a theoretical risk rather than a confirmed harm.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling ATTUNE REVISION POSTERIOR FEMORAL AUGMENT components (Size 9, 12 mm) used in total knee arthroplasty (TKA) revision surgeries. The affected lot numbers are JH9651 and JH9649, with six units distributed in the United States, including Tennessee and Texas.

The recall was initiated due to the potential presence of adhesive residue on the posterior surface of the femoral augment. If undetected and not removed prior to implantation, this residue may cause soft tissue irritation and/or infection in the patient.

Patients who have received or are scheduled to receive this implant should contact their healthcare provider. Surgeons performing knee revision surgeries should visually inspect and clean these components before implantation to ensure no adhesive residue remains on the device.

No illnesses, injuries, or adverse events have been reported in connection with this recall. Patients and healthcare providers with questions can contact DePuy Orthopaedics, Inc.

The recalled product

Product
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • adhesive-residue
  • infection-risk
  • soft-tissue-irritation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lots: JH9651
  • JH9649 GTIN: 10603295383178

Distribution

Distributed nationwide across the United States.

Related recalls

Same category