# FDA recall Z-2549-2025

> **Encore Medical, LP** · Class II · device recall initiated 2025-07-18.

## Product

Brand Name: DJO SURGICAL  Product Name: FA S Altivate Reverse Glenoid Tray  Model/Catalog Number: None  Software Version: NA  Product Description: Enovis" 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.    The AltiVate Reverse¿ Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:  " Severe arthropathy with a grossly deficient rotator cuff;  " Previously failed joint replacement with a grossly deficient rotator cuff;  " Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proxim

## Reason for recall

Their is a potential that the reamer may  kick or bind up  during or immediately prior to use.

## Distribution

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, 	ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.

## Key facts

- **Recall number:** Z-2549-2025
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-18
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2549-2025

## Citation

> AI Analytics. FDA recall Z-2549-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2549-2025. Source: US FDA. Licensed CC0.

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