Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL Recalled by Encore Medical, LP Due to Package labeling for Altivate Reverse Torx Peripheral screw...

Date: May 28, 2025
Company: Encore Medical, LP
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Encore Medical, LP directly.

Affected Products

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 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

Quantity: 200 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 18 states: CO, FL, IL, IN, KY, MA, MI, MN, NC, ND, OH, RI, TN, TX, UT, VA, WV, WI

Affected (18 states)Not affected

About Encore Medical, LP

Encore Medical, LP has 54 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report