Recall Z-1266-2023— DePuy Orthopaedics, Inc.
Class II · Ongoing
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2023-02-15. It names one FDA 510(k) clearance: K191779. Product: Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312. Reason: 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..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-15
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.