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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

DJO Surgical AltiVate Reamers Recalled for Potential to Kick or Bind Up

Agency Publication Date: September 10, 2025
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Summary

Encore Medical, LP is recalling approximately 2,720 DJO Surgical AltiVate reverse glenoid reamer components and tray kits. The affected instruments include reamer heads, boss drills, sleeves, and shoulder prosthesis tray kits used during surgical procedures. The recall was initiated because the reamer tools may kick or bind up immediately prior to or during use, which could interfere with shoulder replacement surgeries. Healthcare facilities should stop using these devices and contact the manufacturer or their distributor to arrange for a return or replacement.

Risk

If the reamer binds or jerks during surgery, it could cause unintended movement of the instrument, potentially leading to bone damage or surgical delays.

What You Should Do

  1. This recall involves DJO Surgical brand AltiVate Reverse Wedge Glenoid reamer heads, boss drills, sleeves, and tray kits used in shoulder replacement procedures.
  2. The affected products can be identified by model numbers 804-06-311, 804-06-312, and 804-06-310. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact the manufacturer, Encore Medical, LP, or your surgical equipment distributor to arrange for the return, replacement, or correction of the affected equipment.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information.

Your Remedy Options

📋Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD
Variants: Non-Sterile
Model / REF:
804-06-311
Lot Numbers:
All Lots
GTIN:
00190446843825

Material: S.S/Nitronic. Recall number Z-2546-2025.

Product: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm
Variants: Non-Sterile
Model / REF:
804-06-312
Lot Numbers:
All Lots
GTIN:
00190446843832

Material: S.S. Recall number Z-2547-2025.

Product: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE
Variants: Non-Sterile
Model / REF:
804-06-310
Lot Numbers:
All Lots
GTIN:
00190446843818

Material: S.S/CoCrMo. Recall number Z-2548-2025.

Product: FA S Altivate Reverse Glenoid Tray
Lot Numbers:
All Lots

Includes shoulder prosthesis components for patients undergoing shoulder arthroplasty. Recall number Z-2549-2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97412
Status: Active
Manufacturer: Encore Medical, LP
Sold By: Hospitals; Surgical Centers; Medical Equipment Distributors
Manufactured In: United States
Units Affected: 4 products (927 units; 907 units; 447 units; 439 kits)
Distributed To: Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Nebraska, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.