Encore Medical, LP recalled 19 units of the EMPOWR 3D Knee Tibial Insert on January 5, 2026. The recall follows the discovery of a packaging error that may cause surgical delays. Healthcare providers and patients should stop using the device immediately.
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
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: N/A
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The EMPOWR 3D Knee Tibial Insert is designed for knee replacement surgeries. Patients typically receive this implant to replace damaged knee joints due to injury or arthritis.
The packaging error may result in the wrong implant being used during surgery, leading to potential delays in procedures or the need for revision surgery.
This recall is not part of a broader industry pattern.
Patients facing a surgical delay may experience prolonged discomfort and a longer recovery process.
The model number and lot number can typically be found on the device's packaging or accompanying documentation.
Expect a timeline of 4-6 weeks for processing refunds or replacements.
Keep records of your device details, any correspondence with the manufacturer, and receipts if available.
The EMPOWR 3D Knee Tibial Insert 5R 14MM, REF: 342-14-705 was found to have a packaging discrepancy. It was distributed in various states including Texas, Iowa, and California since its recall date.
Not sure what to do next? Our guide walks you through the process step by step.
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