Recall Z-2547-2025
Encore Medical, LP · initiated July 18, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot Code: All Lots GTIN: 00190446843832
Reason for recall
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
FDA-determined 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.
Details
- Recall number
- Z-2547-2025
- Initiated
- July 18, 2025
- Posted by FDA
- September 10, 2025
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Quantity
- 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.
- Recalling firm
- Encore Medical, LP, Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2546-2025 Class II | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD…Their is a potential that the reamer may kick or bind up during or immediately prior to use. | 07/18/2025Open, Classified |
| Z-2548-2025 Class II | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE…Their is a potential that the reamer may kick or bind up during or immediately prior to use. | 07/18/2025Open, Classified |
| Z-2549-2025 Class II | Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog…Their is a potential that the reamer may kick or bind up during or immediately prior to use. | 07/18/2025Open, Classified |