The Recall Desk
HighFDA (Devices)·Z-1792-2024·Announced 2024-05-22

TriMed Threaded IM Nails Recalled Due to Out-of-Spec Driver-Socket Defect

TriMed Threaded IM Nail 3.6mm implants are being recalled due to a driver-socket defect that could prevent proper nail pickup or torque application. The recall affects 120 units from lot QM23087 distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a functional defect in a surgical tool. While no injuries or illnesses are reported, the defect creates a risk-of-harm situation where the driver-socket malfunction could compromise surgical placement of an orthopedic implant. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.

Plain-English summary

TriMed Inc. is recalling 120 units of Threaded IM Nail 3.6mm surgical implants (available in 60mm and 65mm lengths) from lot QM23087 (UDI: 00842188127885). The nails contain a driver-socket that does not meet specifications and could prevent proper pickup of nails or application of sufficient torque during surgical implantation.

The affected lot was distributed nationwide to healthcare facilities in Alaska, Arizona, Arkansas, California, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

Healthcare providers who possess this product should verify their inventory against the affected lot number and take appropriate steps to prevent use in patient care.

The recalled product

Product
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
Manufacturer
TriMed Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • device-malfunction
  • surgical-tool-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI:00842188127885/ Lot # QM23087

Distribution

Distributed nationwide across the United States.

Related recalls

Same category