Orthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.
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 of an orthopedic implant with potential for material property changes, qualifying as a risk-of-harm product. No illnesses or injuries have been reported in the source text, placing it at Score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118, Lot JP6452. The recall affects 7 units distributed worldwide, including to the United States, Canada, Poland, Germany, India, Australia, and New Zealand.
The affected units received a higher than specified irradiation dose during manufacturing. This exposure exceeds the validated range for gamma radiation sterilization of these devices and may result in changes to the implant material properties.
Healthcare facilities that received these units should identify and quarantine them and contact DePuy Orthopaedics for guidance on return and replacement procedures.
The recalled product
- Product
- Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
- Manufacturer
- DePuy Orthopaedics, Inc.
- 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: 10603295491095
- Lot: JP6452
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.
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