HIGH

DJO Surgical ALTIVATE Glenoid Reamer Head Recall Expands to 927 Units

DJO Surgical recalled 927 ALTIVATE reverse wedge glenoid reamer heads distributed nationwide in the United States after concerns that the devices may kick or bind up during use. The issue involves model 804-06-311 and non-sterile stainless steel material. Healthcare providers and patients should stop using the device immediately and contact Encore Medical, LP for instructions.

Quick Facts at a Glance

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

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 head is used in shoulder joint procedures to shape the glenoid cavity. Hospitals and surgical centers typically stock such instruments as part of orthopedic kits.

Why This Is Dangerous

If the reamer kicks or binds during use, it can disrupt the surgical procedure and potentially cause injury to the patient or equipment damage.

Industry Context

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

Real-World Impact

Hospitals must quarantine the affected 927 units and coordinate with the manufacturer for guidance. The recall raises potential workflow disruptions and short-term equipment substitution needs.

Practical Guidance

How to identify if yours is affected

  1. Verify model number 804-06-311 on the device label.
  2. Confirm non-sterile status per device documentation.
  3. Cross-check the distributor records to ensure possession of affected units.

Where to find product info

See FDA enforcement page linked in the recall notice for official details and instructions from Encore Medical, LP.

What timeline to expect

Replacement or remediation timelines will be provided by the manufacturer; no universal timeframe is specified.

If the manufacturer is unresponsive

  • Maintain a log of all contact attempts with the manufacturer.
  • Escalate to the hospital or facility compliance office.
  • Consult the FDA recall program for guidance if the manufacturer is unresponsive.

How to prevent similar issues

  • When purchasing surgical instruments, verify sterility status and model numbers before use.
  • Use only updated instrument catalogs from approved manufacturers.
  • Keep a copy of recall notices and confirm disposal or recall actions with the supplier.

Documentation advice

Document all recall communications, quarantine steps, and any replacements or refunds issued.

Product Details

Brand: DJO Surgical. Product: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD. Model/Catalog Number: 804-06-311. Material: Stainless steel/Nitronic. Sterility: Non-sterile. Distribution: US nationwide in 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. Classification: Class II. Quantity: 927 units. Sold at: Unknown. Price: Unknown. Recall Date: 2025-07-18. Manufacturer/Distributor: Encore Medical, LP.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 927 units affected
  • Model 804-06-311
  • Non-sterile stainless steel/Nitronic
  • Distributive reach across 25+ states

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
GENERAL
Injury Types
LACERATIONOTHER

Product Details

Model Numbers
804-06-311
Affected States
ALL
Report Date
September 17, 2025
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

DJO Surgical Recalls 447 ALTIVATE Reverse Glenoid Reamer Sleeve Units (2025)

DJO Surgical is recalling 447 ALTIVATE Reverse Glenoid Reamer Sleeve devices distributed nationwide in the United States. The device may kick or bind up during or immediately prior to use. Healthcare providers and patients should stop using the device and follow recall instructions issued by Encore Medical, LP via email.

DJO Surgical
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