Encore Medical, LP recalled 20 units of its RSP Humeral Socket Insert on January 15, 2026. The recall stems from incorrect labeling on knee and humeral socket implants. Patients and healthcare providers should stop using the device immediately.
Knee and Humeral socket implants contain incorrect labeling.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Encore Medical, LP or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the RSP Humeral Socket Insert, 32MM +4MM, Standard HXe-plus, with model number 509-00-432. It was distributed nationwide, particularly in states including Virginia, Tennessee, and Illinois. The product is classified as Class II.
The recall involves incorrect labeling on the knee and humeral socket implants, potentially leading to patient safety risks. Although specific incidents have not been reported, the incorrect labeling poses a high risk in clinical settings.
No injuries or incidents have been reported related to this recall. The lack of incidents does not diminish the importance of addressing the labeling errors.
Patients and healthcare providers should stop using the recalled device immediately. Contact Encore Medical, LP or your healthcare provider for further instructions and follow the recall guidelines provided.
For more information, contact Encore Medical, LP. Visit their website or use the recall notification letter for instructions.
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