Recall Z-2008-2025 · PHX Shoulder Prosthesis, Reverse Configuration
Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. 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 load
| Date | Jun 23, 2025 (initiated May 28, 2025) |
| Status | Open, Classified |
| Reason | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. |
| Root cause | Process control |
| Action | On May 28, 2025, Enovis (Encore Medical, L.P.) issued a "Urgent: Medical Device Recall" Notification via: E-Mail. Envois is asking consignees to take the following actions: 1. Review your stock for the products and lot numbers for the items to be returned. 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. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA num |
| Quantity | 400 units |
| Distribution | At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233481 | AltiVate Reverse® Glenoid Encore Medical L.P., May 29, 2024 |