Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Reported: March 29, 2023 Initiated: February 15, 2023 #Z-1266-2023
Product Description
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Reason for Recall
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.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 7 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312. Recalled by DePuy Orthopaedics, Inc.. Units affected: 7 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2023. Severity: Moderate. Recall number: Z-1266-2023.
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