TriMed Inc.
TriMed Inc. appears in FDA public data with 19 recalls, 37 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1792-2024, Class II) was initiated on March 19, 2024. Its most recent 510(k) clearance was granted on July 16, 2026.
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 37
- Inspections
- 6
- Compliance Actions
- 1
Known Names
trimed, tri-med
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1792-2024 | Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Thread | March 19, 2024 |
| Z-1791-2024 | Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Thread | March 19, 2024 |
| Z-0932-2024 | Class II | Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W | November 28, 2023 |
| Z-1101-2023 | Class II | RipCord Syndesmosis Button, REF: STA001K | December 22, 2022 |
| Z-0356-2020 | Class II | TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is | September 28, 2018 |
| Z-0358-2020 | Class II | TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc. | September 28, 2018 |
| Z-0355-2020 | Class II | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed | September 28, 2018 |
| Z-0359-2020 | Class II | TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WH | September 28, 2018 |
| Z-0357-2020 | Class II | TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on th | September 28, 2018 |
| Z-1214-2019 | Class II | TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankl | August 24, 2018 |
| Z-0118-2020 | Class II | TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly pack | August 24, 2018 |
| Z-0366-2020 | Class II | TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 | August 15, 2018 |
| Z-2877-2018 | Class II | Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided no | April 16, 2018 |
| Z-2262-2018 | Class II | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x1 | April 13, 2018 |
| Z-2263-2018 | Class II | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) E | April 13, 2018 |
| Z-2265-2018 | Class II | Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) E | April 13, 2018 |
| Z-2264-2018 | Class II | Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x1 | April 13, 2018 |
| Z-1373-2018 | Class II | Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Numbe | January 11, 2018 |
| Z-2849-2016 | Class II | TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. Th | August 29, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD | July 16, 2026 |
| K261241 | TriMed Compression Screws | May 14, 2026 |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar B | January 15, 2026 |
| K252061 | Distal Xtremities System | August 20, 2025 |
| K251134 | RipCord | July 11, 2025 |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | July 10, 2025 |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (He | June 26, 2025 |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metat | May 22, 2025 |
| K243943 | TriMed® Compression Screws | April 10, 2025 |
| K250948 | TriMed Fusion Cup System | April 8, 2025 |
| K243987 | TriMed Elbow and Forearm System | March 19, 2025 |
| K243999 | TriMed Ankle Fixation System | March 19, 2025 |
| K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle | January 15, 2025 |
| K243050 | TriMed Posterior Malleolus Fixation System | November 26, 2024 |
| K241942 | TriMed Bridge Plates | September 17, 2024 |
| K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st M | April 17, 2024 |
| K234040 | TriMed Threaded Intramedullary Nail System | January 18, 2024 |
| K230805 | TriMed Clavicle Fixation System | September 1, 2023 |
| K230749 | TriMed Threaded Intramedullary Nail System | April 17, 2023 |
| K222637 | TriMed Wrist Fixation System 3 | December 21, 2022 |