Brand Name: DJO SURGICAL recallZ-2546-2025 · Encore Medical, LP · initiated Jul 18, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2546-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 18, 2025
- Posted by the FDA
- Sep 10, 2025
- Recalling firm
- Encore Medical, LP
- Quantity
- 927 units
- Product code
- KWS
- FDA submissions
- K233481
- 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.
Product description
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
Code information (models, lots, serial numbers)
Lot Code: Item Number: All Lots GTIN: 00190446843825
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DJO SURGICAL 804-06-311Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall1 report
Other devices under the same FDA submission
20 devices cleared under K233481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 804-06-310Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall12 reports
- DJO SURGICAL 506-04-118Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall1 report
- DJO SURGICAL 506-04-122Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall0 reports
- DJO SURGICAL 506-04-126Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- DJO SURGICAL 506-04-130Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall0 reports
- DJO SURGICAL 804-06-312Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall0 reports
- DJO SURGICAL 508-36-107Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED25 reports
- DJO SURGICAL 508-40-107Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED13 reports
- DJO SURGICAL 508-65-001Encore Medical, L.P. · shoulder prosthesis, reverse configuration13 reports
- DJO SURGICAL 804-06-324Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED12 reports
- DJO SURGICAL 508-32-105Encore Medical, L.P. · shoulder prosthesis, reverse configuration4 reports
- DJO SURGICAL 508-65-000Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97412).
- Z-2547-2025 · Open, ClassifiedBrand 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
- Z-2548-2025 · Open, ClassifiedBrand 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
- Z-2549-2025 · Open, ClassifiedBrand 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…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page