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U.S. Department of Health and Human Services

Class 2 Device Recall Threaded IM Nail

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  Class 2 Device Recall Threaded IM Nail see related information
Date Initiated by Firm March 19, 2024
Date Posted May 10, 2024
Recall Status1 Open3, 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 2		 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 and Original Applicant = TriMed, INC
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