Encore Medical, LP recalled 20 shoulder prosthesis implants on January 15, 2026. Incorrect labeling on the RSP Standard Humeral Socket Insert poses a high hazard risk. Affected products were distributed nationwide across multiple states.
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 recall affects the RSP Standard Humeral Socket Insert, 36MM, model number 509-00-036. The affected lot code is 378P1382. The implants were sold nationwide in states including Virginia, Tennessee, Illinois, Indiana, Michigan, Colorado, Wyoming, Montana, Rhode Island, Massachusetts, New Jersey, Pennsylvania, Missouri, Oklahoma, Louisiana, Florida, and California.
The recalled implants contain incorrect labeling, which may lead to improper usage and potential harm. This situation presents a high hazard risk to patients due to possible complications from incorrect implantation.
No specific incidents or injuries have been reported in connection with this recall. The nature of the labeling error raises concerns for patients and healthcare providers.
Patients and healthcare providers should stop using the device immediately. Contact Encore Medical, LP or your healthcare provider for further instructions on returning the product.
For more information, call Encore Medical, LP. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1460-2026 for details.
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