Quick Facts at a Glance
- Recall Date
- July 18, 2025
- Hazard Level
- HIGH
- Brands
- DJO Surgical, Enovis, Encore Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
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, Enovis, Encore Medical
- Product type
- Shoulder prosthesis accessory or instrument kit
- Model numbers
- AltiVate Reverse Glenoid Tray
- 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
Enovis shoulder devices require precise instrumentation for implantation. The AltiVate reverse prosthesis is used in complex shoulder arthroplasty.
Why This Is Dangerous
A reamer in the kit may kick or bind during use, potentially affecting surgical safety and outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may face delays in procedures; clinicians must halt use of the affected kits.
Practical Guidance
How to identify if yours is affected
- Check the kit lot number against recall notice
- Verify that your facility has the affected 439 kits
- Review device labeling for AltiVate Reverse Glenoid Tray
- Confirm if replacement kits are being sent by Enovis
Where to find product info
FDA enforcement page Z-2549-2025; recall notice from Enovis/Encore Medical
What timeline to expect
Replacement or remediation timelines will be provided by the manufacturer; typical replacement windows span weeks to a couple of months
If the manufacturer is unresponsive
- Log all communications with the manufacturer
- File a complaint with the relevant medical device regulator if needed
- Consider elective procedure postponement if feasible
How to prevent similar issues
- Verify instrument compatibility before procedures
- Maintain updated recall lists
- Ensure sterile processing follows device-specific instructions
Documentation advice
Keep all recall notices, lot numbers, and correspondence; document surgeries affected and any remediation steps
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Product Details
Brand: DJO Surgical. Product: FA S AltiVate Reverse Glenoid Tray. Model/Catalog Number: None. 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. Quantity: 439 kits. Recall date: 2025-07-18. Status: Active.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- Nationwide distribution across 26 states and Puerto Rico
- High-risk Class II device
- Reamer may kick or bind during use
- No injuries reported in provided documentation
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Safety Guide
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