The Recall Desk
HighFDA (Devices)·Z-1267-2023·Announced 2023-03-29

DePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure

DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.

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 a Class II recall for a critical orthopedic implant. While no illnesses or injuries have been reported, the material property changes from excess radiation exposure represent a risk-of-harm to patients with the affected implants.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling the Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM (Part Number 151640507) used in knee replacement surgeries. The recall involves 12 units with lot number JN6613.

The recalled implants received a higher than specified dose of gamma radiation during manufacturing, exceeding the validated range for exposure to these devices. This over-irradiation may result in changes to the implant material properties that could affect device performance.

The implants were distributed worldwide, including the United States, Canada, Poland, Germany, India, Australia, and New Zealand.

The recalled product

Product
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • excess-radiation
  • material-degradation

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)

  • GTIN: 10603295049944
  • Lot: JN6613

Distribution

Distributed nationwide across the United States.

Related recalls

Same category