TriMed Inc.

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
35
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1791-2024Class IITriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, ThreadMarch 19, 2024
Z-1792-2024Class IITriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, ThreadMarch 19, 2024
Z-0932-2024Class IIVolar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7WNovember 28, 2023
Z-1101-2023Class IIRipCord Syndesmosis Button, REF: STA001KDecember 22, 2022
Z-0359-2020Class IITriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHSeptember 28, 2018
Z-0356-2020Class IITriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label isSeptember 28, 2018
Z-0358-2020Class IITriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc.September 28, 2018
Z-0357-2020Class IITriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on thSeptember 28, 2018
Z-0355-2020Class IITriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed September 28, 2018
Z-0118-2020Class IITriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly packAugust 24, 2018
Z-1214-2019Class IITriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed AnklAugust 24, 2018
Z-0366-2020Class IITriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 August 15, 2018
Z-2877-2018Class IIUlnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided noApril 16, 2018
Z-2265-2018Class IINitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) EApril 13, 2018
Z-2262-2018Class IINitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x1April 13, 2018
Z-2264-2018Class IINitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x1April 13, 2018
Z-2263-2018Class IINitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) EApril 13, 2018
Z-1373-2018Class IIHex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part NumbeJanuary 11, 2018
Z-2849-2016Class IITriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. ThAugust 29, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar BJanuary 15, 2026
K252061Distal Xtremities SystemAugust 20, 2025
K251134RipCordJuly 11, 2025
K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)July 10, 2025
K250929TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (HeJune 26, 2025
K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth MetatMay 22, 2025
K243943TriMed® Compression ScrewsApril 10, 2025
K250948TriMed Fusion Cup SystemApril 8, 2025
K243999TriMed Ankle Fixation SystemMarch 19, 2025
K243987TriMed Elbow and Forearm SystemMarch 19, 2025
K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed AngleJanuary 15, 2025
K243050TriMed Posterior Malleolus Fixation SystemNovember 26, 2024
K241942TriMed Bridge PlatesSeptember 17, 2024
K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st MApril 17, 2024
K234040TriMed Threaded Intramedullary Nail SystemJanuary 18, 2024
K230805TriMed Clavicle Fixation SystemSeptember 1, 2023
K230749TriMed Threaded Intramedullary Nail SystemApril 17, 2023
K222637TriMed Wrist Fixation System 3December 21, 2022
K220650TriMed Ripcord DeviceJune 1, 2022
K211783TriMed Threaded Intramedullary Nail SystemAugust 6, 2021