Recall Z-2010-2025
Encore Medical, LP · initiated May 28, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 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 loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA
Codes / lots: Lot Code: Item: 506-04-118 GTIN: 00190446829836 Lot: 5033A1020
Reason for recall
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2010-2025
- Initiated
- May 28, 2025
- Posted by FDA
- June 23, 2025
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Quantity
- 36 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) CE106 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 506-04-130 5039A1021 ALTIVATE REVERSE TORX…
- Recalling firm
- Encore Medical, LP, Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2008-2025 Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm…Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included… | 05/28/2025Open, Classified |
| Z-2009-2025 Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm…Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included… | 05/28/2025Open, Classified |
| Z-2011-2025 Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm…Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included… | 05/28/2025Open, Classified |