Encore Medical Recalls EMPOWR Acetabular System Liners Due to Packaging Discrepancy

What Happened

Encore Medical, LP has initiated a voluntary Class II recall of specific EMPOWR Acetabular System liners. The recall was triggered after a package labeled as a 942-01-40G acetabular system was found to contain a 942-01-36H acetabular system. The firm indicated that several other acetabular system and knee insert devices may also be affected by similar packaging discrepancies.

Which Products Are Affected

The recall involves 49 units of the EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+. The following specific models and lot numbers are affected:

• REF: 942-01-36H (36H); UDI-DI: 00190446309789; Lot: 624Z1032 (Exp: 03-15-2026)
• REF: 942-01-36J (36J); UDI-DI: 00190446309802; Lot: 626Z1021 (Exp: 03-15-2026)
• REF: 942-01-40G (40G); UDI-DI: 00190446309826; Lot: 628Z1034 (Exp: 03-15-2026)
• REF: 942-01-32C (32C); UDI-DI: 00190446309697; Lot: 615Z1026 (Exp: 03-15-2026)

These products were distributed in the following states and territories: Alabama, California, Iowa, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, and Texas.

What You Should Do

Healthcare facilities and surgical centers should immediately inspect their inventory for the affected REF and Lot numbers. Any identified units should be quarantined to prevent use. Facilities should contact Encore Medical, LP at their Austin, Texas location (9800 Metric Blvd, Austin, TX 78758) for instructions on returning the affected products.

Why This Matters

Packaging discrepancies in medical devices can lead to significant surgical delays while staff work to exchange for the correct device. In some instances, such errors could potentially lead to revision surgery.

Source

This information is based on an official recall notification from the FDA. Recall Number: Z-1234-2026.