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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 7 of 60
DeviceModel / ReferenceRegistriesClassStatus
Torx Cortical Screw TRX2.3-09
FDA UDI
Class IIActive
SmallThreadedIMNail 3.6mm (Ti) IMN3.6-65 T
FDA UDI
Class IIActive
Hex Cortical Screw 3.2mm HEX3.2-17
FDA UDI
Class IIActive
Foot Plates MCFR-12
FDA UDI
Class IIActive
CannCompScrew 5.5mm (SelfDrill) L5552
FDA UDI
Class IIActive
Foot Plates MFW4-2
FDA UDI
Class IIActive
Locking Compression Screw 2.4mm NC2410
FDA UDI
Class IIActive
2.7 Cortical Screw TRXC2.7-42 T
FDA UDI
Class IIUnknown
Tools - INS INS-CADDY3.0/3.6-LID
FDA UDI
Class IActive
Tools - HCS HCSCADDY-2.3
FDA UDI
Class IActive
Locking Plates PS15
FDA UDI
Class IIActive
Hex Cortical Screw 2.7mm HEX2.7-32
FDA UDI
Class IIActive
SmallThreadedIMNail 2.4mm (sst) IMN2.4-55 S
FDA UDI
Class IIActive
Tools - Screws DRIVR-SNP AO
FDA UDI
Class IActive
Hex Cortical Screw 2.7mm HEX2.7-14
FDA UDI
Class IIActive
Locking Compression Screw 2.0mm V2011
FDA UDI
Class IIActive
Foot Plates MCP35L
FDA UDI
Class IIActive
RipCord STA001
FDA UDI
Class IIActive
Foot Plates MFUA-6
FDA UDI
Class IIActive
Drills DRILL-3.5/130
FDA UDI
Class IActive
Shuttle Pin SP-1.6/150
FDA UDI
Class IActive
Hex Cortical Screw 2.7mm HEX2.7-09
FDA UDI
Class IIActive
CannCompScrew 4.5mm (SelfDrill) S4544
FDA UDI
Class IIActive
CannCompScrew 2.3mm (SelfDrill) L2318
FDA UDI
Class IIActive
CannCompScrew 2.3mm (SelfDrill) L2325
FDA UDI
Class IIActive
SmallThreadedIMNail 3.0mm (sst) IMN3.0-55 S
FDA UDI
Class IIActive
RipCord STA001K
FDA UDI
Class IIActive
Wireforms US.38
FDA UDI
Class IIActive
Snap-off Screw 1.6mm SNP1.6-12
FDA UDI
Class IIActive
Locking HEX Screw 3.2mm LHEX3.2-20
FDA UDI
Class IIActive
Tools - INS INS-CADDY1.8/2.1-LID
FDA UDI
Class IActive
Foot Plates FFC-5
FDA UDI
Class IIActive
Torx Unthreaded Peg UPEG-12
FDA UDI
Class IIActive
Torx Cortical Screw TRX2.3-17
FDA UDI
Class IIActive
Tools - FPS FPS-MIDFOOT
FDA UDI
Class IActive
CannCompScrew 4.5mm (SelfDrill) S4528
FDA UDI
Class IIActive
CannCompScrew 3.5mm (SelfDrill) L3515
FDA UDI
Class IIActive
Hex Cortical Screw 3.2mm HEX3.2-35
FDA UDI
Class IIActive
Tools - HCS SSS-TRAY
FDA UDI
Class IActive
CannCompScrew 7.3mm (SelfDrill) S7348
FDA UDI
Class IIActive
CannCompScrew 3.0mm (SelfDrill) S3020
FDA UDI
Class IIActive
SmallThreadedIMNail 3.0mm (sst) IMN3.0-50 S
FDA UDI
Class IIActive
CannCompScrew 2.3mm (Classic) C2322
FDA UDI
Class IIActive
Torx Cortical Screw TRX2.3-23
FDA UDI
Class IIActive
Foot Plates MMTP5R-6
FDA UDI
Class IIActive
Hook Plates OHOOKR-17
FDA UDI
Class IIActive
Tools - FPS FPS-TRAY
FDA UDI
Class IActive
3.5 Locking Screw HEXL3.5-22 T
FDA UDI
Class IIActive
Tools -PMF PMF-PCADDY-LID
FDA UDI
Class IIActive
Foot Plates TN-7S
FDA UDI
Class IIActive

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Importers

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Notified Bodies

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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.