SmallThreadedIMNail 3.6mm (Ti) recallZ-1792-2024 · TriMed Inc. · initiated Mar 19, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from TriMed Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
FDA root cause category: Process control
What the company is doing
On 4/3/24, TriMed Inc., issued a "Urgent: Medical Device Recall", to affected consignees via E-Mail. TriMed ask consignees to take the following actions: " If you have the affected product, discontinue further use and quarantine products prior to return. " If a successful implantation was completed no further action is necessary. Only standard monitoring of the patient is required after successful implantation. " Please share this notice with all personnel that may utilize the affected products. Please share this notification to any locations where the affected product may have been transferred to. " Conduct a physical count of the affected product in your possession and record the count on attached response form. Once the response form is completed, email to: [email protected]. Please respond even if you have no affected products in your inventory. " Once the response form is completed and emailed, you will receive an RGA (Return Good Authorization form) as well as a link to generate a label to return the devices via email. Please package the devices, print the return label and ship via FedEx.
Recall details
- Recall number
- Z-1792-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 19, 2024
- Posted by the FDA
- May 10, 2024
- Recalling firm
- TriMed Inc.
- Quantity
- 120 units
- Product code
- HWC
- FDA submissions
- K234040
- Distribution
- US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI.
Product description
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
Code information (models, lots, serial numbers)
UDI:00842188127885/ Lot # QM23087
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SmallThreadedIMNail 3.6mm (Ti) IMN3.6-65 TTrimed, INC. · Screw, fixation, bone1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K234040 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SmallThreadedIMNail 3.6mm (Ti) IMN3.6-60 TTrimed, INC. · Screw, fixation, bone1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94381).
- Z-1791-2024 · Open, ClassifiedTriMed, 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
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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