The Recall Desk
HighFDA (Devices)·Z-1264-2023·Announced 2023-03-29

Orthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure

DePuy Orthopaedics is recalling Attune Revision LPS Tibial Insert devices (Lot JP9016) because they received excessive gamma radiation during manufacturing, which may compromise material properties.

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 risk-of-harm recall for an implanted device where material property degradation from over-irradiation could affect device performance. The FDA classification is Class II, and no illnesses or injuries have been reported. The hazard is theoretical but significant for a long-term orthopedic implant.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212, Lot JP9016. A total of 7 units were distributed worldwide to the US, Canada, Poland, Germany, India, Australia, and New Zealand.

The devices were exposed to a higher than specified dose of gamma radiation during manufacturing. This exposure exceeds the validated range for gamma radiation and may result in changes to the implant material properties.

Healthcare providers and patients with these specific devices should contact DePuy Orthopaedics for guidance regarding appropriate management.

The recalled product

Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • excessive-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: 10603295490968
  • Lot: JP9016

Distribution

Distributed nationwide across the United States.

Related recalls

Same category