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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

TriMed Inc.: Threaded IM Nails Recalled for Driver-Socket Manufacturing Defect

Agency Publication Date: May 10, 2024
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Summary

TriMed Inc. is recalling 262 units of its Threaded IM Nails (3.6mm diameter) because the driver-socket on the device was manufactured out of specification. This defect can prevent surgeons from being able to pick up the nails or apply enough force (torque) during surgical procedures. The recall involves specific 60mm and 65mm non-sterile nails sold throughout the United States. Healthcare providers should stop using these specific lots immediately and contact TriMed Inc. to coordinate the return of affected inventory.

Risk

An out-of-specification driver-socket can lead to the inability to properly grip or tighten the nail during surgery. This could result in surgical delays, improper fixation of the implant, or the need for a replacement device during the procedure.

What You Should Do

  1. Check your medical inventory for TriMed Threaded IM Nails (3.6mm) in 60mm and 65mm lengths labeled with Ref: IMN3.6-60 T or Ref: IMN3.6-65 T.
  2. Verify if your products match the affected lots: Lot # QM23086 (UDI 00842188127878) or Lot # QM23087 (UDI 00842188127885).
  3. Immediately quarantine any affected non-sterile units and do not use them in surgical procedures.
  4. Contact TriMed Inc. at their Santa Clarita, California headquarters to arrange for the return and replacement of the defective nail systems.
  5. For additional information or to report problems, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall via email notification.

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

Affected Products

Product: TriMed Threaded IM Nail 3.6mm, 60mm, TI, Non Sterile
Model / REF:
IMN3.6-60 T
Z-1791-2024
Lot Numbers:
QM23086
Product: TriMed Threaded IM Nail 3.6mm, 65mm, TI, Non Sterile
Model / REF:
IMN3.6-65 T
Z-1791-2024
Lot Numbers:
QM23086
Product: TriMed Threaded IM Nail 3.6mm, 60mm, TI, Non Sterile (Second Lot)
Model / REF:
IMN3.6-60 T
Z-1792-2024
Lot Numbers:
QM23087
Product: TriMed Threaded IM Nail 3.6mm, 65mm, TI, Non Sterile (Second Lot)
Model / REF:
IMN3.6-65 T
Z-1792-2024
Lot Numbers:
QM23087

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94381
Status: Active
Manufacturer: TriMed Inc.
Sold By: TriMed Inc.; Hospital supply chains; Surgical centers
Manufactured In: United States
Units Affected: 2 products (142 units; 120 units)
Distributed To: Alaska, Arkansas, Arizona, California, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin

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.