Encore Medical Recalls EMPOWR 3D Knee Tibial Inserts Over Packaging Errors

What Happened

Encore Medical, LP has initiated a voluntary recall of the EMPOWR 3D Knee Tibial Insert and certain acetabular systems. The recall was prompted by the discovery of a packaging discrepancy where a package labeled as a 942-01-40G acetabular system actually contained a 942-01-36H system. The firm noted that other knee insert devices may also be affected by similar labeling errors, which could lead to incorrect components being present during surgical procedures.

Which Products Are Affected

The recall specifically identifies the following medical device:

• Product Name: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE
• Reference Number (REF): 342-14-705
• Recall Number: Z-1233-2026
• Lot Number: 139T1075A
• UDI-DI: 00888912167529
• Expiration Date: 03-12-2026
• Quantity: 19 units

The affected units were distributed across several states and territories, including: Alabama, California, Iowa, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, Texas, and Puerto Rico.

What You Should Do

Healthcare facilities, surgeons, and medical supply managers should immediately inspect their inventory for the affected lot number (139T1075A). Any identified units should be quarantined and removed from surgical availability to prevent use. Facilities should contact Encore Medical, LP at their Austin, Texas office for further instructions regarding the return or exchange of the mislabeled devices.

Why This Matters

Packaging discrepancies in surgical components pose a significant risk to patient safety. Such errors can result in unexpected surgical delays while staff attempt to source the correct device or, in more serious cases, may necessitate revision surgery if an incorrect component is implanted before the error is identified.

Source

This information is based on an official recall notice from the FDA.