FDA Device recall Z-2010-2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version:…
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version:… by Encore Medical, citing package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2010-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-28 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Encore Medical |
| Distribution | CO, FL, IL, IN, KY, MA, MI, MN, NC, ND, OH, RI, TN, TX, UT, VA, WI, WV |
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
Reason
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Identifiers
| code_info | Lot Code: Item: 506-04-118 GTIN: 00190446829836 Lot: 5033A1020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2010-2025%22
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