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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 22 of 60

Device	Model / Reference	Registries	Class	Status
Wire Plates	WFP3	FDA UDI	Class II	Active
HPS Cortical Screw 1.2mm	PHCS1.2-13	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-16	FDA UDI	Class II	Active
Tools - LHS	LHS-SCREW4.5-LID	FDA UDI	Class I	Active
2.7 Locking Screw	HEXL2.7-38 T	FDA UDI	Class II	Active
HPS Cortical Screw 1.5mm	PHCS1.5-18	FDA UDI	Class II	Active
Tools - UOS	OCC	FDA UDI	Class I	Active
Volar Fixed Angle Plates	VPPL-3-6	FDA UDI	Class II	Active
HPS Cortical Screw 2.0mm	MCCS2.0-14	FDA UDI	Class II	Active
Volar Bearing Plates	VLBPL-11-7	FDA UDI	Class II	Active
Volar Peg Threaded	VPG-T-18	FDA UDI	Class II	Active
HeadCannCompScrew 7.3mm	HL73108	FDA UDI	Class II	Active
Tools - FPS	GUIDEVAL-2.7	FDA UDI	Class I	Active
Osteotomy Compression Plates	UOCP	FDA UDI	Class II	Active
Foot Plates	MCP35R	FDA UDI	Class II	Active
HeadCannCompScrew 2.3mm	HL2325	FDA UDI	Class II	Active
HeadCannCompScrew 7.3mm	HS73108	FDA UDI	Class II	Active
Hook Plates	MHOOK-9	FDA UDI	Class II	Active
Tools - SHD	SHD-SCREW3.5-LID	FDA UDI	Class I	Active
CannCompScrew 3.5mm (SelfDrill)	L3524	FDA UDI	Class II	Active
3.5 Cortical Screw	HEXC3.5-10 T	FDA UDI	Class II	Active
Drills	DRILL-2.30	FDA UDI	Class I	Active
Tools - Screws	GUIDE-1.75/2.30	FDA UDI	Class I	Active
CannCompScrew 3.0mm (SelfDrill)	L3016	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3524	FDA UDI	Class II	Active
CannCompScrew 7.3mm (Classic)	C7384	FDA UDI	Class II	Active
FPS Non-Locking Screw 3.5mm	CNS3.5-20	FDA UDI	Class II	Active
Tools - Screws	DVTX-8 NP	FDA UDI	Class I	Active
SmallThreadedIMNail 2.7mm (Ti)	IMN2.7-40 T	FDA UDI	Class II	Active
Volar Peg Threaded	VPG-T-22	FDA UDI	Class II	Active
CannCompScrew 3.0mm (sst)	L3012 S	FDA UDI	Class II	Active
Locking Cortical Screw 3.2mm	LCBS3.2-28	FDA UDI	Class II	Active
SmallThreadedIMNail 3.0mm (sst)	IMN3.0-40 S	FDA UDI	Class II	Active
Generic Instruments	HNDL-T JC	FDA UDI	Class I	Active
Clavicle Plates	CPSLATL-12	FDA UDI	Class II	Active
FPS Non-Locking Screw 2.7mm	CNS2.7-22	FDA UDI	Class II	Active
Posterior Malleolar Plates	PMLA 6-4	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-54	FDA UDI	Class II	Active
FPS Locking Screw 3.5mm	CLS3.5-20	FDA UDI	Class II	Active
3.5 VA Locking Screw	HEXV3.5-30 T	FDA UDI	Class II	Active
Drills	DRILL-2.5/110TSA	FDA UDI	Class I	Active
Tools - HCS	HCS-SCREW3.5-LID	FDA UDI	Class I	Active
CLASSIC Radial Column Pin Plate	RPP5	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-60	FDA UDI	Class II	Active
HPS Locking Screw 1.5mm	PHLS1.5-06	FDA UDI	Class II	Active
Foot Plates	EOP-4S	FDA UDI	Class II	Active
Volar Bearing Plates	VBEAR-3-7N	FDA UDI	Class II	Active
Cancellous Screw 3.8mm	CAB3.8-22	FDA UDI	Class II	Active
Generic Instruments	XPANDR	FDA UDI	Class I	Active
2.3 Locking Screw	TRXL2.3-38 T	FDA UDI	Class II	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.