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
This recall is currently active, issued September 10, 2025.
- Recall Initiated
- July 18, 2025
- Posted
- September 10, 2025
- Recall Number
- Z-2546-2025
- Quantity
- 927 units
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
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.
Lot / Code Info
Lot Code: Item Number: All Lots GTIN: 00190446843825
Root Cause
Device Design
Action Taken
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.