Class II — Potential Health Hazard

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

AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Recalled by Encore Medical, LP Due to Complaints have been received concerning the humeral stem...

Date: June 28, 2021
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

AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000

Quantity: N/A

Why Was This Recalled?

Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

Where Was This Sold?

This product was distributed to 34 states: AL, AZ, AR, CA, CO, FL, GA, HI, IL, IN, KY, LA, ME, MD, MI, MN, MS, MO, MT, NV, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV

Affected (34 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