Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804
FDA device recall Z-2547-2025 · posted 2025-09-10 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- Their is a potential that the reamer may kick or bind up during or immediately prior to use.
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KWS
- Quantity affected
- 907 units
- 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.
- Date initiated
- 2025-07-18
- Date posted
- 2025-09-10
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AltiVate Reverse® Glenoid (K233481) | Encore Medical L.P. | 2024-05-29 |