The Recall Desk

Manufacturer

TriMed Inc.

19 recalls in our database name TriMed Inc. as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
1
Most recent
2024-05-22

Of the 19 recalls from TriMed Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • HighFDA (Devices)·Z-1791-2024·2024-05-22

    TriMed Threaded IM Nail System Recalled for Driver-Socket Defect

    TriMed Inc. is recalling 142 units of Threaded IM Nails with an out-of-specification driver-socket that could prevent proper surgical nail fixation and torque application.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1792-2024·2024-05-22

    TriMed Threaded IM Nails Recalled Due to Out-of-Spec Driver-Socket Defect

    TriMed Threaded IM Nail 3.6mm implants are being recalled due to a driver-socket defect that could prevent proper nail pickup or torque application. The recall affects 120 units from lot QM23087 distributed nationwide.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2024·2024-02-07

    Volar Bearing Plate wrist fixation systems recalled for bearing dislodgement

    TriMed Inc. recalls Volar Bearing Plate wrist fixation systems because bearings may dislodge from distal peg holes during implantation, potentially compromising fracture fixation. Approximately 270 units distributed in five states.

    Product
    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,
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1101-2023·2023-02-15

    RipCord Syndesmosis Button suture may break during orthopedic surgery

    The RipCord Syndesmosis Button's pull suture can break when excessive tension is applied during orthopedic surgery. TriMed Inc. is recalling 76 units due to this structural failure risk.

    Product
    RipCord Syndesmosis Button, REF: STA001K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2020·2019-11-20

    TriMed Locking Drill Guide Recall Due to Epoxy Coating Defect

    TriMed Inc. is recalling 1,042 Locking Drill Guides because the epoxy coating on the instruments can pop off.

    Product
    TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2020·2019-11-20

    TriMed Recalls Olecranon Hook Plates Due to Unqualified Hole Modification

    TriMed Inc. is recalling 583 Olecranon Hook Plates because angled holes may have been modified from specifications without full qualification.

    Product
    TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2020·2019-11-20

    TriMed Wrist Hook Impactors Recalled for Rust Risk

    TriMed Inc. is recalling 561 Wrist Hook Dorsal and Volar Impactors because they can rust due to an improper manufacturing process.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0358-2020·2019-11-20

    TriMed Peg Guide Extender Recalled Due to Rusting Spring Hazard

    TriMed Inc. is recalling 1,903 Peg Guide Extenders because the spring can rust due to the steel used. The product was distributed nationwide and to several foreign countries.

    Product
    TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2020·2019-11-20

    TriMed Countersink Instruments Recalled Due to Epoxy Coating Defect

    TriMed Inc. is recalling 99 nonsterile 1.7mm countersink instruments because the epoxy coating can pop off. The recall covers nationwide and specific foreign distribution.

    Product
    TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0357-2020·2019-11-20

    TriMed Hex Driver Recall Due to Epoxy Coating Defect

    TriMed Inc. is recalling 467 Hex Drivers because the epoxy coating may pop off. The recall covers units distributed nationwide and to several foreign countries.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0118-2020·2019-10-16

    TriMed Dorsal Wrist Hook Plate Recalled for Structural Integrity Issues

    TriMed Inc. is recalling 5 Dorsal Wrist Hook Plates due to unqualified design modifications that may compromise structural integrity.

    Product
    TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1214-2019·2019-05-01

    TriMed Hex Cortical Screw Recalled for Shorter Than Specified Length

    TriMed Inc. is recalling 13 Hex Cortical Screws from the Ankle Fixation System because they are shorter than the intended design specification.

    Product
    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 HEX4.0-4
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2877-2018·2018-08-29

    TriMed Ulnar Osteotomy Compression Plate Recalled for Manufacturing Defect

    TriMed Inc. is recalling 722 Ulnar Osteotomy Compression Plates because instrument holes are located on the wrong side of the plate.

    Product
    Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2265-2018·2018-06-27

    TriMed Nitinol Staple Recall Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 1,194 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2263-2018·2018-06-27

    TriMed Nitinol Staples Recalled Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 323 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2262-2018·2018-06-27

    TriMed Recalls Nitinol Staples Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 532 Nitinol staples because quarterly sterilization dose audit records could not be found, posing a risk of patient infection.

    Product
    Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2264-2018·2018-06-27

    TriMed Recalls Nitinol Surgical Staples Due to Sterilization Record Gaps

    TriMed Inc. is recalling 706 units of Nitinol Surgical Staples because quarterly sterilization dose audits could not be verified, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1373-2018·2018-04-18

    TriMed Inc. Recalls Hex Drivers Due to Epoxy Color Band Migration

    TriMed Inc. is recalling 1,525 hex drivers because the epoxy color band may migrate down the shaft or onto sterilization trays after sterilization.

    Product
    Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2849-2016·2016-09-28

    TriMed Recalls Semi-Tubular Plates Due to Screw Failure During Implantation

    Trimed Inc is recalling 30 units of SMTP-10 Semi-Tubular Plates because a non-locking screw passed through a plate hole during implantation.

    Product
    TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractur
    Category
    Medical Device
    Distribution
    Distributed nationwide