Encore Medical, LP recalled 14 EMPOWR 3D Knee implants on January 15, 2026. The implants contain incorrect labeling that poses a risk to patients. Healthcare providers should stop using the device immediately and follow recall instructions.
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 EMPOWR 3D KNEE INS, 7L 16MM, VE with model number 341-16-707. The affected lot code is Lot: 151T1055A and GTIN: 00888912167147. This product was distributed nationwide across several states, including Virginia, Tennessee, and California.
The recall stems from incorrect labeling on the knee and humeral socket implants. This mislabeling can lead to improper use and potential harm to patients.
No specific incidents have been reported regarding injuries or deaths related to this recall. The risk level is classified as high due to the nature of the medical device.
Patients and healthcare providers must stop using the EMPOWR 3D Knee implants immediately. Contact Encore Medical, LP or a healthcare provider for further instructions on returning the product.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1459-2026. For direct assistance, reach out to Encore Medical, LP.
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