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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- DJO Surgical
- Product type
- Glenoid Reamer Head
- Model numbers
- 804-06-311
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 18, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify model number 804-06-311 on the device label.
- Confirm non-sterile status per device documentation.
- 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.
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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
- Non-sterile stainless steel/Nitronic
- Distributive reach across 25+ states
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Safety Guide
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