Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number:...
FDA Device Recall #Z-2549-2025 — Class II — July 18, 2025
Recall Summary
| Recall Number | Z-2549-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 18, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Encore Medical, LP |
| Location | Austin, TX |
| Product Type | Devices |
| Quantity | 439 kits |
Product Description
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. The AltiVate Reverse¿ Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: " Severe arthropathy with a grossly deficient rotator cuff; " Previously failed joint replacement with a grossly deficient rotator cuff; " Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; " Bone defect in proximal humerus; " Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; " Inflammatory arthritis including rheumatoid arthritis; " Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP¿ Monoblock and AltiVate Reverse¿ humeral stems are intended for cemented or cementless use. Enovis" instrumentation consists of devices and their accessories used in surgical procedures. Implantation of Enovis" products should only be performed with Enovis" instrumentation or instrumentation distributed by Enovis". Enovis" instruments and instrument cases are generally composed of titanium, stainless steel, aluminum, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing the cleaning, sterilization, and drying cycle that has been validated and detailed below. Instrument cases do not provide a sterile barrier and must be used in conjunction with FDA cleared sterilization wrap to maintain sterility. Instruments are provided non-sterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below. Component: NA
Reason for Recall
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Distribution Pattern
US Nationwide distribution in the states of 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.
Lot / Code Information
Lot Code: All GTIN:
Other Recalls from Encore Medical, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1459-2026 | Class II | Brand Name: EMPOWR 3D KNEE Product Name: EMPOW... | Jan 15, 2026 |
| Z-1458-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) ... | Jan 15, 2026 |
| Z-1460-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) ... | Jan 15, 2026 |
| Z-1233-2026 | Class II | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: ... | Jan 5, 2026 |
| Z-1234-2026 | Class II | EMPOWR Acetabular System: Liner, 10 degree Hood... | Jan 5, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.