FDAFDA · Food and drugs·Recall number Z-1266-2023
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Published March 29, 2023 · Recall initiated: February 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- Lot
- GTIN: 10603295490869; Lot: JP6464
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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