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.
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 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.
- Affected units
- 12
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.
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 →Related recalls
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