Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catal…

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

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

On July 29, 2025, Enovis issued a "Urgent Medical Device Recall Notification via Email to affected consignees. On August 4, 2025, Enovis issued an update to the recall notification via E-Mail requesting consignees rework affected trays and returned affected products. Enovis asked consignees to take the following actions: 1. Continue using the wedge reamer assembly while carefully inspecting and following the specific details in the supplied Quality Bulletin. 2. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3. Please see the attached quality Bulletin 4. By 9/13/25, the firm will reach out regarding reworking and returning trays. 5. Acknowledge receipt of notification.

• FDA enforcement recordOfficial FDA database entry for Z-2549-2025
• FDA 510(k) clearance · K233481The device's official FDA premarket clearance record
• FDA device classification · FSMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Encore Medical, LPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.