Class II — Potential Health Hazard

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

REVERSE PROSTHESIS SHOULDER SYSTEM Recalled by Encore Medical, LP Due to Reverse shoulder prosthesis package that should contain 5mmx30...

Date: August 22, 2023
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

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Quantity: 70

Why Was This Recalled?

Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

Where Was This Sold?

This product was distributed to 14 states: AZ, FL, IN, IA, KY, MN, NY, OH, RI, SC, TX, VA, WA, WI

Affected (14 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