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.
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 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.
- Hazard
- device-defect
- radiation-exposure
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.
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