TriMed, Inc.
TriMed, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 19 FDA device recalls on record.
Top product codes for TriMed, Inc.
FDA recalls by TriMed, Inc.
10 most recent of 19- 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 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
- Z-1792-2024 — 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
- Z-0932-2024 — Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies.
- Z-1101-2023 — RipCord Syndesmosis Button, REF: STA001K
- Z-0356-2020 — TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- Z-0355-2020 — TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- Z-0358-2020 — TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- Z-0357-2020 — TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- Z-0359-2020 — TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
- Z-1214-2019 — TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by TriMed, Inc.
- K262344 — Large Compression Screws
- K262032 — TriMed Non-Spanning Wrist Fusion Plates (4 models)
- K261241 — TriMed Compression Screws
- K254002 — TriMed Volar Bearing Plates (6 models)
- K252061 — Distal Xtremities System
- K251134 — RipCord
- K251945 — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
- K250929 — TriMed Ulnar Osteotomy System (4 models)
- K250935 — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
- K243943 — TriMed® Compression Screws
- K250948 — TriMed Fusion Cup System
- K243987 — TriMed Elbow and Forearm System
- K243999 — TriMed Ankle Fixation System
- K243569 — TriMed Wrist Fixation System (10 models)
- K243050 — TriMed Posterior Malleolus Fixation System
- K241942 — TriMed Bridge Plates
- K233863 — TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-
- K234040 — TriMed Threaded Intramedullary Nail System
- K230805 — TriMed Clavicle Fixation System
- K230749 — TriMed Threaded Intramedullary Nail System
- K222637 — TriMed Wrist Fixation System 3
- K220650 — TriMed Ripcord Device
- K211783 — TriMed Threaded Intramedullary Nail System
- K192696 — TriMed ASET Foot Plating System
- K190166 — TriMed Nitinol Staple System
- K151735 — TriMed Humeral Supracondylar Fixation System
- K112794 — EOS SMALL BONE FIXATION SYSTEM
- K112509 — TRIMED CLAVICLE FIXATION SYSTEM
- K111266 — EASYLOCK OSTEOSYSTEM
- K102785 — TRIMED RADIOCARPAL FUSION SYSTEM
- K101375 — TRIMED X-FIX
- K093676 — OMNITECH LARGE, TRIMED COMPRESSION SCREW
- K091156 — TRIMED STERILE PRODUCT
- K081348 — TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
- K071876 — CROSS.BONE
- K060041 — TRIMED BONE PLATES
- K050681 — OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
- K043263 — TRIMED OSTEOTOMY PLATE
Data sourced from openFDA. This site is unofficial and independent of the FDA.