The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0632-2022·Announced 2022-02-16

Orthopedic knee replacement component recalled for adhesive residue contamination

DePuy Orthopaedics is recalling 3 units of ATTUNE REVISION DISTAL FEMORAL AUGMENT due to adhesive residue that could cause tissue irritation or infection if not detected before surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA Class II medical device recall involves an implantable orthopedic component with potential to cause infection or tissue damage if a manufacturing defect is not detected before implantation. No illnesses or injuries have been reported, placing this in the risk-of-harm category where injury has not yet been documented.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 3 units of ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM, a knee replacement component (Product Number 154706001, Lot JJ3389) intended for use in total knee arthroplasty revision surgeries. The recalled units were distributed nationwide in Tennessee and Texas.

The recall was initiated because the affected augments may have adhesive residue on the posterior surface of the device. If this residue is not detected and removed before the device is surgically implanted, it could cause soft tissue irritation and/or infection at the surgical site.

Surgeons and hospitals that received this component should verify their inventory against the recalled lot number (JJ3389) and inspect the posterior surface for adhesive residue before use. Any units matching the recall parameters should not be implanted without thorough inspection and cleaning. Patients who have received this device as part of revision surgery should consult with their healthcare provider if they experience signs of infection or tissue irritation at the surgical site.

The recalled product

Product
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
3

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 (1)

  • Lots: JJ3389 GTIN: 10603295382775

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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