HIGH

DJO Surgical ALTIVATE Reversed Wedge Glenoid Reamer Boss Drill 6.5mm Recalled in 2025 for Binding or

DJO Surgical recalled 907 units of the ALTIVATE reverse wedge glenoid reamer boss drill 6.5mm sold nationwide in the United States. The device may kick or bind up during use. Healthcare providers and patients should stop using the device immediately and follow recall instructions from Encore Medical, LP.

Quick Facts at a Glance

Recall Date
July 18, 2025
Hazard Level
HIGH
Brand
DJO Surgical
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Encore Medical, LP or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The ALTIVATE reverse wedge glenoid reamer boss drill is a surgical instrument used in orthopedic procedures. It is non-sterile and intended for professional use.

Why This Is Dangerous

A kick or binding during use can lead to unintended movements, increasing risk to patients and surgeons.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

High risk during surgical use; potential to affect patient safety and procedure outcomes; immediate discontinuation required.

Practical Guidance

How to identify if yours is affected

  1. Check model number 804-06-312 on the device.
  2. Verify non-sterile description in packaging or documentation.
  3. Review recall notification email from Encore Medical for instructions.

Where to find product info

FDA enforcement page Z-2547-2025 provides official recall details.

What timeline to expect

Refunds or replacements terms are not specified; expect process to follow Encore Medical recall procedures within typical 4-8 weeks.

If the manufacturer is unresponsive

  • Escalate to hospital risk management.
  • File a consumer safety complaint with CPSC if manufacturer is nonresponsive.

How to prevent similar issues

  • Verify device sterility status before use in any surgical instrument recalls.
  • Coordinate with hospital supply chain to track recalled devices.
  • Use only devices with current recall status cleared by hospital regulatory team.

Documentation advice

Keep recall notice, purchase records, model validation, and all correspondence with manufacturer.

Product Details

Brand: DJO Surgical. Product: ALTIVATE Reverse Wedge Glenoid Reamer Boss Drill, 6.5mm. Model/Catalog: 804-06-312. Description: Stainless steel, non-sterile. Quantity: 907 units. Distribution: United States nationwide in AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI. Status: Active recall as of 2025-07-18.

Reported Incidents

No injuries or incidents have been reported in the provided data.

Key Facts

  • 907 units recalled
  • Model 804-06-312
  • Nationwide US distribution in listed states
  • High hazard level

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
LACERATIONELECTRICALOTHER

Product Details

Model Numbers
804-06-312
Affected States
ALL
Report Date
September 17, 2025
Recall Status
ACTIVE

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