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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Altivate Reverse Torx Peripheral Screws Recalled for Incorrect Size Labeling

Agency Publication Date: June 23, 2025
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Summary

Encore Medical, LP is recalling 836 units of Altivate Reverse Torx Peripheral Screws because the packaging identifies a different size than the screw actually contained inside. These screws are part of shoulder replacement systems intended to restore mobility and reduce pain. Because the labeling is incorrect, a surgeon might inadvertently select and use the wrong size screw during a procedure. If you have had shoulder surgery involving these implants, contact your healthcare provider for more information. No incidents or injuries have been reported to date.

Risk

Incorrect sizing labels on the packaging can lead to the use of an inappropriate screw size during shoulder surgery. This error could result in surgical delays while the correct part is located or complications related to an improper fit of the implant components.

What You Should Do

  1. This recall affects Altivate Reverse Torx Peripheral Screws in sizes 18mm, 22mm, 26mm, and 30mm used in shoulder replacement procedures.
  2. Hospital staff and surgeons should check their inventory for model numbers 506-04-118, 506-04-122, 506-04-126, and 506-04-130.
  3. Verify your stock against the affected lot numbers, which include codes 5033A1020, 5035A1018, 5037A1011, 5037A1017, 5039A1015, and 5039A1021.
  4. Stop using the recalled screws immediately and set aside any affected products in a secure location to prevent their use in surgery.
  5. Contact the manufacturer, Encore Medical, LP, or your authorized distributor to arrange for the return and replacement of the mislabeled devices.
  6. For additional questions or to report a problem, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Corrective action for clinical device

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm
Variants: 18mm
Model / REF:
506-04-118
Lot Numbers:
5033A1020
GTIN:
00190446829836

Quantity: 36 units

Product: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm
Variants: 22mm
Model / REF:
506-04-122
Lot Numbers:
5035A1018
GTIN:
00190446829843

Quantity: 200 units

Product: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm
Variants: 26mm
Model / REF:
506-04-126
Lot Numbers:
5037A1011
5037A1017
GTIN:
00190446829850

Quantity: 400 units

Product: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm
Variants: 30mm
Model / REF:
506-04-130
Lot Numbers:
5039A1015
5039A1021
GTIN:
00190446829867

Quantity: 200 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96917
Status: Active
Manufacturer: Encore Medical, LP
Sold By: RFK Medical Inc.; Evolution Medical; Valor Medical Solutions; Matrix Orthopedics Surgical Devices; Joint Ventures Medical LLC; WHISKEY TRAIL ORTHOPEDICS LLC - AUS; McCants Medical, LLC; Florida Direct - FSW Medical; Great Lakes Medical; Certus Medical LLC; I & S Medical; Osteo Solutions; Procore Medical, LLC; Medsource
Manufactured In: United States
Units Affected: 4 products (400 units; 200 units; 36 units; 200 units)
Distributed To: Virginia, North Dakota, Minnesota, Colorado, Utah, Texas, Wisconsin, Tennessee, Florida, Illinois, Indiana, Michigan, West Virginia, Kentucky, Ohio, North Carolina, Rhode Island, Massachusetts

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.