Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130
FDA device recall Z-2011-2025 · posted 2025-06-23 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Action taken
- 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 number and shipping label to return the affected product. 4. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- PHX
- Quantity affected
- 200 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 Evol
- Date initiated
- 2025-05-28
- Date posted
- 2025-06-23
- 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 |