Recall Z-1791-2024— TriMed Inc.

Name: FDA recall Z-1791-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-19

Class II · Ongoing

Class II FDA medical device recall by TriMed Inc., initiated 2024-03-19. It names one FDA 510(k) clearance: K234040. 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. Reason: Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque..

Recalling firm: TriMed Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-19
Firm location: Santa Clarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K234040 — TriMed Threaded Intramedullary Nail SystemTriMed, Inc.·cleared 2024-01-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.