DJO SURGICAL ALTIVATE REVERSE WEDGE GLENOID REAMER 6.5mm Recall: Risk of Binding During
DJO SURGICAL recalls 6.5mm ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL (model 804-06-312) due to potential binding during use. Affected units may kick or bind, causing injury. Contact DJO SURGICAL for details.
Use caution until it’s fixed
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Contact the company
What happened, in plain English
DJO SURGICAL is recalling their 6.5mm ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL (model 804-06-312) because it may kick or bind during use, potentially causing injury. This is a medical device used in surgeries. Read more at govinfonow.com/recall/51771-djo-surgical-altivate-reverse-wedge-glenoid-reamer-6-5mm-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/51771-djo-surgical-altivate-reverse-wedge-glenoid-reamer-6-5mm-recall · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2547-2025
Cite this page
“DJO SURGICAL ALTIVATE REVERSE WEDGE GLENOID REAMER 6.5mm Recall: Risk of Binding During.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51771-djo-surgical-altivate-reverse-wedge-glenoid-reamer-6-5mm-recall. Based on FDA recall #Z-2547-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2547-2025%22&limit=1).
Why it’s dangerous
The reamer may kick or bind during or immediately before use, which could cause injury. This happens because the device might not move smoothly when being used in surgical procedures.
Who’s affected
Surgical professionals and patients using this specific medical device are affected. Those with the model number 804-06-312 are most at risk.
How to tell if you have this one
Check for the model number 804-06-312 on the product. This 6.5mm ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL is sold by DJO SURGICAL and used in medical procedures.
- Brand
DJO SURGICAL- Product
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2546-2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile; Lot Code: Item Number: All Lots GTIN: 00190446843825 | 927 units |
| Z-2547-2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile; Lot Code: All Lots GTIN: 00190446843832 | 907 units |
| Z-2548-2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile; Lot Code: All Lots GTIN: 00190446843818 | 447 units |
| Z-2549-2025 | 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; Lot Code: All GTIN: | 439 kits |
What to do — step by step
Check Product Model
Look for the model number 804-06-312 on the device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 26 states.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Nebraska, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2547-2025 (July 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2547-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.