The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1265-2023·Announced 2023-03-29

Attune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation

DePuy Orthopaedics is recalling 7 units of the Attune Revision Limb Preservation System Tibial Insert (Lot JP9022) that received higher than specified gamma radiation doses. The over-irradiation may cause changes to implant material properties.

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 is a Class II FDA medical device recall with no reported injuries or hospitalizations. The hazard involves potential material property changes from over-irradiation, which is theoretical rather than confirmed. Per the rubric, recalls without reported harm and with theoretical hazards score at most 3 (High).

Plain-English summary

DePuy Orthopaedics, Inc. is recalling the Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM (Part Number 151760226) in Lot JP9022. A total of 7 units were distributed worldwide, including the United States, Canada, Poland, Germany, India, Australia, and New Zealand.

The recalled units received a higher than specified irradiation dose during manufacturing, exceeding the validated range for gamma radiation exposure established for these devices. The over-irradiation may result in changes to the implant material properties.

Patients who have received this implant should consult their orthopedic surgeon with concerns about this recall. Healthcare providers and facilities should verify whether they have this product in inventory.

The recalled product

Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
7

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: 10603295491033
  • Lot: JP9022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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