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 Sleeve
- Model numbers
- 804-06-310
- 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 Glenoid Reamer Sleeve is a surgical instrument used in shoulder arthroplasty to prepare the glenoid. Hospitals and surgeons rely on precise instrumentation for joint replacement procedures.
Why This Is Dangerous
The device has a potential to kick or bind up during use, which could lead to unexpected movement during a surgical procedure and possible patient or operator injury.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
If used, the potential for intraoperative distraction or injury could disrupt procedures and require device replacement or surgical revisions.
Practical Guidance
How to identify if yours is affected
- Check model 804-06-310 on the device label or packaging
- Confirm device is ALTIVATE Reverse Glenoid Reamer Sleeve with the included catalog number
- Review recall notice emailed by Encore Medical, LP
Where to find product info
Recall notice via Encore Medical email and FDA enforcement pages
What timeline to expect
Manufacturer guidance will outline replacement or remediation timelines; follow all instructions as issued
If the manufacturer is unresponsive
- Document all outreach attempts to Encore Medical; report to hospital safety officer; file a CPSC consumer complaint if appropriate
- Contact healthcare provider for alternatives and escalation
How to prevent similar issues
- Verify device model numbers before procedures
- Maintain an updated inventory of surgical instruments and sterilization status
- Monitor recall communications via hospital procurement or safety office
Documentation advice
Keep the recall notice, batch/lot numbers, and all email communications; photograph labels and packaging for records
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Product Details
Model/catalog number: 804-06-310. Distribution: US 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. Sold since: Unknown. Price: Unknown. Quantity: 447 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed nationwide in the US
- Hazard: may kick or bind up during use
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Safety Guide
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