Medartis Inc.: APTUS TriLock Bone Screws Recalled for Incorrect Screw Length

Agency Publication Date: May 14, 2024

Summary

Medartis Inc. is recalling 110 units of the APTUS 2.8 TriLock Screw 22mm (Part No. A-5850.22/1), which are metal bone fixation fasteners used in surgical procedures. The recall was initiated because the screws contained in the packaging are actually 16mm long instead of the labeled 22mm length. Consumers and healthcare providers should contact the manufacturer or their healthcare facility to ensure any unused affected inventory is returned and that appropriate medical follow-up is conducted if these were used in surgery.

Risk

The use of a bone screw that is shorter than intended (16mm instead of 22mm) may result in inadequate fixation of the bone, potentially leading to implant loosening, delayed healing, or the need for additional revision surgery.

What You Should Do

Identify if you have the affected product by checking the packaging for APTUS 2.8 TriLock Screw 22mm, HD7, Part No. A-5850.22/1, and Lot No. 24377397.
Immediately stop using any inventory from Lot No. 24377397 and quarantine the affected units to prevent clinical use.
Contact your healthcare provider or surgeon if you have recently undergone a bone fixation procedure where the APTUS system was used to discuss any concerns regarding the implant length.
Contact Medartis Inc. at their Warsaw, Indiana headquarters or through your local distributor to arrange for the return of the incorrect 16mm screws and to receive the correct 22mm replacements.
For additional information or to report concerns, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Healthcare provider notification and product return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg

Model / REF:

A-5850.22/1

UDI-DI: 76300378022PA

Lot Numbers:

24377397

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94445

Status: Active

Manufacturer: Medartis Inc.

Sold By: Specialty medical distributors; Hospitals

Manufactured In: United States

Units Affected: 110 units

Distributed To: Texas

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 · 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.

Summary

What You Should Do

Identify if you have the affected product by checking the packaging for APTUS 2.8 TriLock Screw 22mm, HD7, Part No. A-5850.22/1, and Lot No. 24377397.

Immediately stop using any inventory from Lot No. 24377397 and quarantine the affected units to prevent clinical use.

Contact your healthcare provider or surgeon if you have recently undergone a bone fixation procedure where the APTUS system was used to discuss any concerns regarding the implant length.

Contact Medartis Inc. at their Warsaw, Indiana headquarters or through your local distributor to arrange for the return of the incorrect 16mm screws and to receive the correct 22mm replacements.

For additional information or to report concerns, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.