Z-1791-2024Class II

TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail...

Name: Z-1791-2024 TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail...
Creator: TriMed Inc.
Published: 2024-03-19
License: https://open.fda.gov/license/

Trimed Inc / initiated 2024-03-19 / Open, Classified / root cause: manufacturing process

FDA source

TriMed Inc. began a recall of 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... on 2024-03-19. FDA classified it as Class II and gives the reason as "Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1791-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-19
Posted: 2024-05-10
Recalling firm: Trimed Inc
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
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA root 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: [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.
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.
Product codes and lots: UDI: 00842188127878/ Lot # QM23086

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1791-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1791-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10
Z-1792-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10

Product code HWC

K234040Class IITriMed Threaded Intramedullary Nail SystemTriMed, Inc. / cleared 2024-01-18

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)