Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX… — Class II medical device recall Z-2008-2025
Ongoing recall by Encore Medical, LP, reported 2025-07-02, distributed in CO, FL, IL, IN, KY, MA, MI, MN…. Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included pro
| Recall number | Z-2008-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2025-05-28 |
| Classified | 2025-06-23 |
| Reported by FDA | 2025-07-02 |
| Distributed | CO, FL, IL, IN, KY, MA, MI, MN, NC, ND, OH, RI, TN, TX, UT, VA, WI, WV |
| Quantity | 400 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00190446829850 |
| Lot numbers | 5037A1011, 5037A1017 |
| Model numbers | 506-04-126 |
Product
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 loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA
Reason for recall
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2008-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.