Lower riskMedical device recall · FDA · Published May 28, 2025
Encore Medical ALTIVATE REVERSE Torx Screw Recall: Incorrect Size Labeling
Encore Medical recalls ALTIVATE REVERSE Torx Peripheral screws (model 506-04-126) due to incorrect size labeling on packaging. This may cause improper use in shoulder replacements.
“Encore Medical ALTIVATE REVERSE Torx Screw Recall: Incorrect Size Labeling.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52187-encore-medical-altivate-reverse-torx-screw-recall-incorrect-size-labeling. Based on FDA recall #Z-2008-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2008-2025%22&limit=1).
Encore Medical, LP recalled ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm units because package labeling lists a different size than the actual product, according to the FDA on May 28, 2025.
The package labeling for the Altivate Reverse Torx Peripheral screw contains a different size than the actual included product.
Context
GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since May 31, 2017. Other recent recalls of similar products include EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026), Encore Medical RSP Humeral Socket Insert Recall (Jan. 15, 2026), and Encore Medical EMPOWR Acetabular System Recall (Jan. 5, 2026).
How to tell if you have this one
Check for model number 506-04-126 on the packaging. These screws were sold with lot codes 5037A1011 and 5037A1017.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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; Lot Code: Item: 506-04-126 GTIN: 00190446829850 Lot\s: 5037A1011 / 5037A1017
400 units
Z-2009-2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 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; Lot Code: Item: 506-04-122 GTIN: 00190446829843 Lot: 5035A1018
200 units
Z-2010-2025
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; Lot Code: Item: 506-04-118 GTIN: 00190446829836 Lot: 5033A1020
36 units
Z-2011-2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 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; Lot Code: Item: 506-04-130 GTIN: 00190446829867 Lot/s: 5039A1015 / 5039A1021
200 units
Based on the official FDA remedy
What to do — step by step
Check Product Labeling
Verify the model number on the packaging matches 506-04-126.
Where it went and when
Where it was distributed
Distributed in 18 states.
Listed by the agency
Not listed
FDA 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),…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2008-2025 (May 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2008-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.