HIGH

DJO Surgical Recalls Reamer Head Due to Binding Hazard

DJO Surgical recalled 927 units of the Altivate Reverse Wedge Glenoid Reamer Head on July 18, 2025. The recall follows reports that the device may kick or bind up during use. Healthcare providers and patients must stop using the product immediately.

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

Product Details

The recalled product is the Altivate Reverse Wedge Glenoid Reamer Head, model number 804-06-311. It is made from S.S/Nitronic and is non-sterile. The product was distributed nationwide in the United States.

The Hazard

Users may experience a kick or bind up of the reamer during or just before use. This malfunction can lead to potential injuries and complications.

Reported Incidents

There are no specific incident counts or injury reports mentioned. The potential for harm remains a serious concern.

What to Do

Stop using the Altivate Reverse Wedge Glenoid Reamer Head immediately. Contact Encore Medical, LP or your healthcare provider for further instructions and follow the recall instructions provided.

Contact Information

For more information, contact Encore Medical, LP via email. Visit the FDA website for details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2546-2025.

Key Facts

  • Model Number: 804-06-311
  • Quantity Recalled: 927 units
  • Class II recall
  • Non-sterile surgical instrument
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
804-06-311
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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