Agency classClass IIOur severity:High FDA (Devices)·Z-1266-2023·Announced 2023-03-29

Attune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure

DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade 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 an FDA Class II recall affecting an orthopedic implant that received excess gamma radiation exposure during manufacturing. While no illnesses or injuries have been reported, the excess radiation may cause material property changes in the implant, creating a potential risk of device malfunction. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics is recalling the Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM (Part Number 151760312), Lot JP6464. The affected units, totaling 7 devices, received a higher than specified dose of gamma radiation during manufacturing, which exceeds the validated exposure range for these implants. This excess radiation exposure may cause changes to the implant's material properties, potentially affecting its performance or long-term durability.

The implants were distributed worldwide, including to the United States, Canada, Poland, Germany, India, Australia, and New Zealand. Patients or healthcare providers who may have received an implant from the affected lot should contact their healthcare provider or DePuy Orthopaedics directly for guidance on whether the implant is affected and any appropriate next steps.

The recalled product

Product: Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: device-defect
radiation-exposure
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: 10603295490869
Lot: JP6464

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 →

Same manufacturer · DePuy Orthopaedics, Inc.

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Orthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
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Same hazard · device defect