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
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
- Surgical Drill/Imaging Reamer
- Model numbers
- 804-06-312
- Sizes
- 6.5mm
- Sold at
- Unknown
- 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 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
- Check model number 804-06-312 on the device.
- Verify non-sterile description in packaging or documentation.
- 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.
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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
- Nationwide US distribution in listed states
- High hazard level
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Safety Guide
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