Class 2 Device Recall Threaded IM Nail

• Date Initiated by Firm: March 19, 2024
• Date Posted: May 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1791-2024
• Recall Event ID: 94381
• 510(K)Number: K234040
• Product Classification: Screw, fixation, bone - Product Code HWC
• 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
• Code Information: UDI: 00842188127878/ Lot # QM23086
• Recalling Firm/ Manufacturer: TriMed Inc.; 27533 Avenue Hopkins; Santa Clarita CA 91355-3910
• For Additional Information Contact: Megan Rissler; 661-255-7406
• Manufacturer Reason for Recall: Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 142 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HWC