# FDA recall Z-2010-2025

> **Encore Medical, LP** · Class II · device recall initiated 2025-05-28.

## Product

Brand Name: ALTIVATE REVERSE  Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm  Model/Catalog Number: 506-04-118  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

## Reason for recall

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

## Distribution

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 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm      1       506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm      4 Valor Medical Solutions South Texas (TX) CE118        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm      6       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm      17 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm       1 Joint Ventures Medical LLC Wisconsin (WI) CE121        506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm        24       506-04-126 5037A1017 ALTIVATE REVERSE TORX PERI

## Key facts

- **Recall number:** Z-2010-2025
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-28
- **Report date:** 2025-07-02

- **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-2010-2025

## Citation

> AI Analytics. FDA recall Z-2010-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2010-2025. Source: US FDA. Licensed CC0.

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