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 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.
The 942-01-40G acetabular system package contained the incorrect 942-01-36H acetabular system. This discrepancy may lead to surgical delays, affecting patient care and outcomes.
No specific incidents or injuries were reported in connection with this recall. The potential for surgical delays is a significant concern.
Stop using the device immediately. Contact Encore Medical, LP or your healthcare provider for further instructions on the recall.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1233-2026.
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