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Trimed, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
27533 Avenue Hopkins, Santa Clarita, CA, 91355
LinkedIn
—
Facebook
—
Phone
+1(661)255-7406
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3001236812
DUNS Number
138041277

Catalogue (2974)

Page 28 of 60
DeviceModel / ReferenceRegistriesClassStatus
CannCompScrew 7.3mm (SelfDrill) L7360
FDA UDI
Class IIActive
SmallThreadedIMNail 2.4mm (Ti) IMN2.4-50 T
FDA UDI
Class IIActive
FPS Locking Screw 2.0mm CLS2.0-18
FDA UDI
Class IIActive
Cortical Screws 3.2mm CBS3.2-18
FDA UDI
Class IIActive
2.3 Locking Screw TRXL2.3-30 T
FDA UDI
Class IIActive
Fusion Cups FC07
FDA UDI
Class IIActive
4.0 VA Locking Screw TRXV4.0-26 T
FDA UDI
Class IIActive
Torx 2.4 Threaded Peg TPEG2.4-12
FDA UDI
Class IIActive
Wireforms VBP32
FDA UDI
Class IIActive
Locking Cortical Screw 3.2mm LCBS3.2-20
FDA UDI
Class IIActive
Foot Plates MFC-6
FDA UDI
Class IIActive
Torx Smooth Peg 2.3mm SPEG2.3-46
FDA UDI
Class IIActive
HPS Cortical Screw 2.0mm MCCS2.0-16
FDA UDI
Class IIActive
CannCompScrew 3.5mm (SelfDrill) L3533
FDA UDI
Class IIActive
Tools - Screws GUIDE-2.00/2.70
FDA UDI
Class IActive
Tools - HCS HCS-SCREW1.7
FDA UDI
Class IActive
Tools - TSS GUIDE-STPL
FDA UDI
Class IActive
Tools - AFS AFS-SCREW (O)
FDA UDI
Class IActive
CannCompScrew 3.0mm (SelfDrill) L3012
FDA UDI
Class IIActive
Volar Fixed Angle Plates VPPR-5-8
FDA UDI
Class IIActive
Tools - SFC STF-RMR-S
FDA UDI
Class IActive
Foot Plates MFW2-4
FDA UDI
Class IIActive
2.7 Cortical Screw TRXC2.7-38 T
FDA UDI
Class IIActive
FPS Locking Screw 3.0mm CLS3.0-12
FDA UDI
Class IIActive
Calcaneal Plates CLPR-66
FDA UDI
Class IIActive
HeadCannCompScrew 2.3mm HL2324
FDA UDI
Class IIActive
Foot Plates SP20-3M
FDA UDI
Class IIActive
Foot Plates MTPL-9L
FDA UDI
Class IIActive
2.3 Cortical Screw TRXC2.3-24 T
FDA UDI
Class IIActive
Distal Humerus Plates HSLATR-7
FDA UDI
Class IIActive
Torx Smooth Peg 2.3mm SPEG2.3-32
FDA UDI
Class IIActive
2.7 VA Locking Screw TRXV2.7-32 T
FDA UDI
Class IIActive
Elastic Staples ES-12x15x17
FDA UDI
Class IIActive
Foot Plates MFOL-5
FDA UDI
Class IIUnknown
2.7 Locking Screw HEXL2.7-36 T
FDA UDI
Class IIActive
Volar Peg Unthreaded VPG-U-30
FDA UDI
Class IIActive
HPS Cortical Screw 1.5mm PHCS1.5-04
FDA UDI
Class IIActive
Hex Cortical Screw 2.7mm HEX2.7-26
FDA UDI
Class IIActive
3.5 Cortical Screw HEXC3.5-48 T
FDA UDI
Class IIActive
CannCompScrew 3.0mm (Classic) C3028
FDA UDI
Class IIActive
Clavicle Plates CPSLATL-9
FDA UDI
Class IIActive
Foot Plates MOPL-4
FDA UDI
Class IIActive
Calcaneal Plates CLPR-54
FDA UDI
Class IIActive
Tools - WS3 WS3-VOLARF-LID
FDA UDI
Class IActive
Cann. Hex Cortical Screw 3.2mm HEX3.2C-20
FDA UDI
Class IIActive
K-Wires WIRE-1.6/230
FDA UDI
Class IIActive
SmallThreadedIMNail 2.7mm (sst) IMN2.7-30 S
FDA UDI
Class IIActive
Tools-HPS GAUGE-HPS
FDA UDI
Class IActive
2.3 VA Locking Screw TRXV2.3-22 T
FDA UDI
Class IIActive
Hex Cortical Screw 2.7mm HEX2.7-27
FDA UDI
Class IIActive

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Importers

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Authorities

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FDA Recalls (18)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Mar 19, 2024Z-1792-2024—open, classified

Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

Mar 19, 2024Z-1791-2024—open, classified

Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

Nov 28, 2023Z-0932-2024—open, classified

Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.

Dec 22, 2022Z-1101-2023—open, classified

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.

Sep 28, 2018Z-0356-2020—open, classified

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

Sep 28, 2018Z-0357-2020—open, classified

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

Sep 28, 2018Z-0355-2020—open, classified

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

Sep 28, 2018Z-0358-2020—open, classified

The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.

Sep 28, 2018Z-0359-2020—open, classified

The WHD/WHV impactors can rust over time due to an improper manufacturing process.

Aug 24, 2018Z-1214-2019—terminated

The bone screw is shorter than the intended design specification.

Aug 24, 2018Z-0118-2020—terminated

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.

Aug 15, 2018Z-0366-2020—terminated

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.

Apr 16, 2018Z-2877-2018—terminated

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

Apr 13, 2018Z-2265-2018—terminated

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.

Apr 13, 2018Z-2264-2018—terminated

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.

Apr 13, 2018Z-2263-2018—terminated

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.

Apr 13, 2018Z-2262-2018—terminated

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.

Jan 11, 2018Z-1373-2018—terminated

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.