TriMed Threaded IM Nail System Recalled for Driver-Socket Defect
TriMed Inc. is recalling 142 units of Threaded IM Nails with an out-of-specification driver-socket that could prevent proper surgical nail fixation and torque application.
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 an FDA Class II medical device recall for a surgical instrument with a functional defect that prevents proper nail fixation. Although no illnesses or injuries have been reported, the hazard presents a direct risk of harm and fits the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
TriMed Inc. is recalling 142 units of its Threaded IM Nail systems (model numbers IMN3.6-60 T and IMN3.6-65 T, Lot #QM23086). These are surgical instruments used in orthopedic procedures to stabilize bone fractures.
The recalled nails contain a driver-socket that does not meet manufacturing specifications. This defect could prevent the surgical instrument from properly engaging the nail or applying sufficient torque during installation. These failures could result in incomplete or failed surgical fixation, potentially requiring additional surgical intervention.
The affected units were distributed nationwide to medical facilities in 22 states. The recall affects only devices with Lot #QM23086 (UDI: 00842188127878).
Medical facilities that have received these devices should discontinue use immediately and contact TriMed Inc. for guidance on replacement or credit options.
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.
- Hazard
- device-defect
- torque-failure
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: 00842188127878/ Lot # QM23086
Distribution
Distributed nationwide across the United States.
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