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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 51 of 60
DeviceModel / ReferenceRegistriesClassStatus
Tools - FPS GUIDE-L1.4/1.6
FDA UDI
Class IActive
Tools - LHS LHS-SCREW4.5
FDA UDI
Class IActive
Hex Cortical Screw 3.2mm HEX3.2-18
FDA UDI
Class IIActive
Foot Plates MCFL-12
FDA UDI
Class IIActive
3.5 Cortical Screw TRXC3.5-08 T
FDA UDI
Class IIActive
Foot Plates HP27-M
FDA UDI
Class IIActive
HeadCannCompScrew 3.0mm HL3023
FDA UDI
Class IIActive
Volar Peg Unthreaded VPG-U-20
FDA UDI
Class IIActive
Tools - Screws DVTX-8/110 AO
FDA UDI
Class IActive
Foot Plates MCFL-6
FDA UDI
Class IIActive
S.A. - Volar Bearing Plates VLBPR-7-4
FDA UDI
Class IIActive
Tools - HCS CSCADDY-1.7
FDA UDI
Class IActive
CannCompScrew 7.3mm (Classic) C7348
FDA UDI
Class IIActive
CannCompScrew 7.3mm (Classic) CL7368
FDA UDI
Class IIActive
CannCompScrew 3.5mm (SelfDrill) L3511
FDA UDI
Class IIActive
HeadCannCompScrew 2.3mm HL2321
FDA UDI
Class IIActive
Hex Cortical Screw 2.7mm HEX2.7-24
FDA UDI
Class IIActive
4.0 VA Locking Screw TRXV4.0-40 T
FDA UDI
Class IIActive
HeadCannCompScrew 7.3mm HS7388
FDA UDI
Class IIActive
SmallThreadedIMNail 2.7mm (Ti) IMN2.7-60 T
FDA UDI
Class IIActive
Tools - SFC RMRSFC-20
FDA UDI
Class IActive
Tools - AFS AFS-FIB
FDA UDI
Class IActive
Generic Instruments OBC
FDA UDI
Class IActive
Foot Plates LAPL-7
FDA UDI
Class IIActive
Torx Cortical Screw TRX2.3-26
FDA UDI
Class IIActive
SmallThreadedIMNail 1.8mm (Ti) IMN1.8-20 T
FDA UDI
Class IIActive
Foot Plates LAP0L-5
FDA UDI
Class IIActive
Tools -PMF PMF-SCADDY-LID
FDA UDI
Class IIActive
Torx Smooth Peg SPEG1.8-12
FDA UDI
Class IIActive
2.7 Locking Screw HEXL2.7-22 T
FDA UDI
Class IIActive
Foot Plates FFS-4
FDA UDI
Class IIActive
Tools - DHF IMPCT-DHMN
FDA UDI
Class IActive
Tools - WS3 WS3-TRAY
FDA UDI
Class IActive
CannCompScrew 3.5mm (SelfDrill) L3513
FDA UDI
Class IIActive
Tools - Screws GAUGE30
FDA UDI
Class IActive
CannCompScrew 3.0mm (SelfDrill) L3027
FDA UDI
Class IIActive
2.7 Locking Screw HEXL2.7-16 T
FDA UDI
Class IIActive
Foot Plates MFW8-2
FDA UDI
Class IIActive
Tools - HPS HPS-CADDY1.5
FDA UDI
Class IActive
2.7 Locking Screw HEXL2.7-32 T
FDA UDI
Class IIActive
Hex Cortical Screw 3.2mm HEX3.2-45
FDA UDI
Class IIActive
2.7 Cortical Screw TRXC2.7-46 T
FDA UDI
Class IIUnknown
Locking HEX Screw 3.2mm LHEX3.2-27
FDA UDI
Class IIActive
Tools - SHD SHD-SCREW1.7-LID
FDA UDI
Class IActive
Foot Plates MTP0L-6N
FDA UDI
Class IIActive
HPS Locking Screw 1.5mm PHLS1.5-05
FDA UDI
Class IIActive
HeadCannCompScrew 4.5mm HS4542
FDA UDI
Class IIActive
CannCompScrew 7.3mm (SelfDrill) L7372
FDA UDI
Class IIActive
FPS Non-Locking Screw 3.5mm CNS3.5-34
FDA UDI
Class IIActive
4.0 Cortical Screw TRXC4.0-22 T
FDA UDI
Class IIActive

Related Companies

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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.