Threaded IM Nail (TriMed) – Driver-Socket Specification Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
TriMed Inc.
Lot Codes / Batch Numbers
UDI: 00842188127878/ Lot # QM23086
Products Sold
UDI: 00842188127878/ Lot # QM23086
TriMed Inc. is recalling TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threade due to Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Recommended Action
Per FDA guidance
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: Quality@trimedortho.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026