Reported Jul 2, 2025 · Ongoing

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number:…

Encore Medical, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Encore Medical, LP · 9800 Metric Blvd · Austin, TX · 78758-5445

Is this the product you have?

  • Brand NameALTIVATE
  • REVERSE Product NameALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm
  • Model/Catalog Number506-04-126
  • Software VersionNA
  • Product DescriptionEncore 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
  • ComponentNA
Lot codes and dates
  • Lot CodeItem: 506-04-126
  • GTIN00190446829850 Lot\s: 5037A1011 / 5037A1017
Amount recalled
400 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.