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Trimed, INC.

Last updated September 17, 2026

Information

Country: US
Address: 27533 Avenue Hopkins, Santa Clarita, CA, 91355
Website: trimedortho.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(661)255-7406
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3001236812
DUNS Number: 138041277

Catalogue (2974)

Page 4 of 60

Device	Model / Reference	Registries	Class	Status
HeadCannCompScrew 3.5mm	HL3517	FDA UDI	Class II	Active
HPS Cortical Screw 1.5mm	PHCS1.5-14	FDA UDI	Class II	Active
2.7 Locking Screw	TRXL2.7-42 T	FDA UDI	Class II	Active
Tools - HPS	PICK-BRKT	FDA UDI	Class I	Active
Torx Smooth Peg 2.3mm	SPEG2.3-34	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-49	FDA UDI	Class II	Active
HPS Cortical Screw 1.5mm	PHCS1.5-16	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-44	FDA UDI	Class II	Active
Tools - WFS	BRG-INSRTR BRKT	FDA UDI	Class I	Active
Tools - Screws	TAP-2.3 AO	FDA UDI	Class I	Active
Tools - Screws	HXDRIVR-2.5/180 AO	FDA UDI	Class I	Active
Tools - FPS	GDUHP-1.8	FDA UDI	Class I	Active
Locking Plates	PCB8	FDA UDI	Class II	Active
Tools - Screws	DVHX-2.0/070C AO	FDA UDI	Class I	Active
3.5 VA Locking Screw	TRXV3.5-26 T	FDA UDI	Class II	Active
2.7 Locking Screw	HEXL2.7-26 T	FDA UDI	Class II	Active
HeadCannCompScrew 2.3mm	HL2320	FDA UDI	Class II	Active
CannCompScrew 2.3mm (Classic)	C2310	FDA UDI	Class II	Active
Volar Fixed Angle Plates	VFPR-3-7S	FDA UDI	Class II	Active
Tools - RSO	GSRSO-2	FDA UDI	Class I	Active
CannCompScrew 7.3mm (SelfDrill)	S73100	FDA UDI	Class II	Active
Tools -PMF	GUIDEMINI-2.0	FDA UDI	Class I	Active
Foot Plates	MCFR-9	FDA UDI	Class II	Active
SmallThreadedIMNail 3.6mm (Ti)	IMN3.6-70 T	FDA UDI	Class II	Active
Tools - DHF	GSOO-2.0	FDA UDI	Class I	Unknown
Hex Cortical Screw 3.2mm	HEX3.2-24	FDA UDI	Class II	Active
Clavicle Plates	CPSMIDL-8	FDA UDI	Class II	Active
CannCompScrew 3.5mm (Classic)	C3524	FDA UDI	Class II	Active
HPS Locking Screw 1.5mm	PHLS1.5-08	FDA UDI	Class II	Active
2.7 Locking Screw	TRXL2.7-16 T	FDA UDI	Class II	Active
Tools - FMS	TAP-5.5C AO	FDA UDI	Class I	Active
Tools - AFS	MGUIDE-4.0	FDA UDI	Class I	Active
Foot Plates	SP27-6	FDA UDI	Class II	Active
Cortical Screws 3.2mm	CBS3.2-08	FDA UDI	Class II	Active
FMS Screw 5.5mm	JHEX5545	FDA UDI	Class II	Active
Locking Compression Screw 2.4mm	NC2424	FDA UDI	Class II	Active
Tools - SHD	SHD-SCREW3.5	FDA UDI	Class I	Active
Locking Cortical Screw 2.7mm	LCBS2.7-36	FDA UDI	Class II	Active
Distal Humerus Plates	HSMNPR-4	FDA UDI	Class II	Active
CannCompScrew 4.5mm (SelfDrill)	S4540	FDA UDI	Class II	Active
CannCompScrew 7.3mm (Classic)	C7360	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-31	FDA UDI	Class II	Active
2.7 Locking Screw	HEXL2.7-18 T	FDA UDI	Class II	Active
CannCompScrew 7.3mm (SelfDrill)	S7384	FDA UDI	Class II	Active
Tools - UFC	FCGAUGE	FDA UDI	Class I	Active
Locking Cortical Screw 2.7mm	LCBS2.7-10	FDA UDI	Class II	Active
K-Wires	WIRE-0.7/120	FDA UDI	Class I	Active
Hook Plates	HOOK-6	FDA UDI	Class II	Active
Pin Plates	RPIN-3	FDA UDI	Class II	Active
Tools - FMS	IMPCT-FMS	FDA UDI	Class I	Active

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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.

Date	Recall No.	Class	Status	Reason
Mar 19, 2024	Z-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, 2024	Z-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, 2023	Z-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, 2022	Z-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, 2018	Z-0356-2020	—	open, classified	The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Sep 28, 2018	Z-0357-2020	—	open, classified	The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Sep 28, 2018	Z-0355-2020	—	open, classified	The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Sep 28, 2018	Z-0358-2020	—	open, classified	The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
Sep 28, 2018	Z-0359-2020	—	open, classified	The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Aug 24, 2018	Z-1214-2019	—	terminated	The bone screw is shorter than the intended design specification.
Aug 24, 2018	Z-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, 2018	Z-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, 2018	Z-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, 2018	Z-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, 2018	Z-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, 2018	Z-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, 2018	Z-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, 2018	Z-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.