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.
- Affected units
- 142
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
Part of a larger recall action
This product is one of 2 recalled by TriMed Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · TriMed Inc.
See all →- HighTriMed Threaded IM Nails Recalled Due to Out-of-Spec Driver-Socket Defect
FDA (Devices) · 2024-05-22
- HighVolar Bearing Plate wrist fixation systems recalled for bearing dislodgement
FDA (Devices) · 2024-02-07
- HighRipCord Syndesmosis Button suture may break during orthopedic surgery
FDA (Devices) · 2023-02-15
- ModerateTriMed Peg Guide Extender Recalled Due to Rusting Spring Hazard
FDA (Devices) · 2019-11-20
- ModerateTriMed Countersink Instruments Recalled Due to Epoxy Coating Defect
FDA (Devices) · 2019-11-20
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22