Encore Medical, LP recalled 49 units of the EMPOWR Acetabular System on January 5, 2026. Packaging errors may cause surgical delays, potentially affecting patient safety. Healthcare providers should stop using these devices 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 recall involves the EMPOWR Acetabular System with multiple model numbers: 942-01-36H, 942-01-36J, 942-01-40G, and 942-01-32C. These devices were distributed across several states, including Texas, New York, and California.
The packaging error means that a 942-01-40G acetabular system package may contain a 942-01-36H acetabular system. This discrepancy could lead to surgical delays, which may impact patient care.
No specific incidents or injuries have been reported at this time. However, the potential for surgical delays poses a significant risk to patient safety.
Stop using the affected devices immediately. Follow the recall instructions provided by the manufacturer and contact Encore Medical, LP or your healthcare provider for further guidance.
For more information, contact Encore Medical, LP. Visit the recall link at the FDA website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1234-2026.
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