Encore Medical, LP recalls Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-12…

Recall date

May 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2009-2025

FDA classification

Class II

Brand / firm

Encore Medical, LP

Sold / distributed

At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106 506-04-126 5037A101…

Why it was recalled

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA