Santa Clarita, CA, United States
TriMed Inc. recalls
10 recalls recorded since 2018, most recently on 19 March 2024. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls10
Ongoing (FDA)4
Terminated or completed6
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 March 2024
- Reason
- Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
- Distribution
- US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1792-2024, 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
- 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
Ongoing Class II Medical devices
- Recall started
- 28 November 2023
- Reason
- Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
- Distribution
- US: FL, MI, AL, NY, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 use
Ongoing Class II Medical devices
- Recall started
- 22 December 2022
- Reason
- Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
- Distribution
- US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1101-2023
- RipCord Syndesmosis Button, REF: STA001K
Ongoing Class II Medical devices
- Recall started
- 28 September 2018
- Reason
- The epoxy on Apex manufactured epoxy-coated instruments can pop off.
- Distribution
- Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0355-2020, Z-0358-2020, Z-0356-2020, Z-0357-2020, Z-0359-2020
- TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- 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.
- 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.
Terminated Class II Medical devices
- Recall started
- 24 August 2018
- Terminated
- 28 December 2020
- Reason
- The bone screw is shorter than the intended design specification.
- Distribution
- US Distribution to states of FL and MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 24 August 2018
- Terminated
- 28 April 2021
- Reason
- Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
- Distribution
- Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0118-2020
- 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, C
Terminated Class II Medical devices
- Recall started
- 15 August 2018
- Reason
- The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
- Distribution
- US Nationwide distribution in the states of MD, UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0366-2020
- 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
Terminated Class II Medical devices
- Recall started
- 16 April 2018
- Terminated
- 28 January 2021
- Reason
- Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate
- Distribution
- Worldwide Distribution in the state of TX and countries of Australia, China Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2877-2018
- 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 f
Terminated Class II Medical devices
- Recall started
- 13 April 2018
- Terminated
- 22 January 2021
- Reason
- During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
- Distribution
- U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2264-2018, Z-2263-2018, Z-2262-2018, Z-2265-2018
- 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
- Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
- Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
- 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
Terminated Class II Medical devices
- Recall started
- 11 January 2018
- Terminated
- 18 January 2024
- Reason
- Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
- Distribution
- US, China, Latin America
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1373-2018
- 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 Numb
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.