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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/Surgical Equipment

APTUS TriLock Screws Recalled for Sizing Mix-Up

Agency Publication Date: March 10, 2026
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Summary

Medartis AG has recalled 126 units of APTUS TriLock Screws due to a packaging mix-up where 2.5mm and 2.8mm diameter screws were swapped across specific lots. These screws are used in surgical fixation systems for fractures and arthrodesis in the hand, forearm, shoulder, and foot. Because the screws may not match their labeled size, surgeons could inadvertently use an incorrect diameter during a procedure.

Risk

The use of a screw with an incorrect diameter during surgery can lead to improper fixation of bones, potential device failure, or the need for revision surgery to correct the hardware.

What You Should Do

  1. Identify if you have the affected products by checking the lot numbers on the packaging: 2.5 TriLock Screw 16mm (Lot 25472432) and 2.8 TriLock Screw 16mm (Lot 25467933).
  2. Stop using the recalled device.
  3. Contact Medartis AG or your distributor to arrange for the return, replacement, or correction of the affected screws.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: APTUS 2.5 TriLock Screw 16mm, HD7, 1/Pkg
Variants: 2.5mm outer diameter, 16mm length
Model / REF:
A-5750.16/1
Lot Numbers:
25472432

Used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.

Product: APTUS 2.8 TriLock Screw 16mm, HD7, 1/Pkg
Variants: 2.8mm outer diameter, 16mm length
Model / REF:
A-5850.16/1
Lot Numbers:
25467933

Used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98353
Status: Active
Manufacturer: Medartis AG
Sold By: Medical distributors; Hospitals
Manufactured In: Switzerland
Units Affected: 2 products (0; 126)
Distributed To: Indiana, Pennsylvania

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.