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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 30 of 60

Device	Model / Reference	Registries	Class	Status
Generic Instruments	WIREGAUGE-1.6/150	FDA UDI	Class I	Active
2.7 VA Locking Screw	TRXV2.7-46 T	FDA UDI	Class II	Unknown
Tools - UOS	UOS-SMALL-LID	FDA UDI	Class I	Active
HPS Cortical Screw 1.5mm	PHCS1.5-05	FDA UDI	Class II	Active
Tools - HPS	GUIDE-1.6/2.0	FDA UDI	Class I	Active
4.0 Cortical Screw	TRXC4.0-48 T	FDA UDI	Class II	Active
K-Wires	WIRE-1.1/100	FDA UDI	Class II	Active
HeadCannCompScrew 4.5mm	HS4564	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-25	FDA UDI	Class II	Active
CannCompScrew 2.3mm (sst)	L2314 S	FDA UDI	Class II	Active
CannCompScrew 5.5mm (SelfDrill)	L5564	FDA UDI	Class II	Active
Tools - LHS	HDSINK-7.3	FDA UDI	Class I	Active
Torx Smooth Peg	SPEG1.8-24	FDA UDI	Class II	Active
Foot Plates	MCFL-17L	FDA UDI	Class II	Active
Tools - AFS	AFS-TIB-LID	FDA UDI	Class I	Active
CannCompScrew 1.7mm (Classic)	C1710	FDA UDI	Class II	Active
Tools - DHF	SINKDHF-9.0	FDA UDI	Class I	Active
FPS Locking Screw 2.3mm	CLS2.3-16	FDA UDI	Class II	Active
Tools - HCS	HCS-TRAY	FDA UDI	Class I	Active
Tools - LHS	HDSINK-4.5	FDA UDI	Class I	Active
CannCompScrew 3.0mm (SelfDrill)	L3022	FDA UDI	Class II	Active
Tools - Screws	HXDRIVR-2.5 AO	FDA UDI	Class I	Active
Tools - UOS	COMPC-UOS	FDA UDI	Class I	Active
HeadCannCompScrew 7.3mm	HL7372	FDA UDI	Class II	Active
Foot Plates	MTPR-7	FDA UDI	Class II	Active
Hex Cortical Screw 2.7mm	HEX2.7-44	FDA UDI	Class II	Active
Saw Blades	OSB-LS	FDA UDI	Class I	Active
Nail Peg	IPEG3.2-18	FDA UDI	Class II	Active
2.7 Locking Screw	TRXL2.7-44 T	FDA UDI	Class II	Active
Tools - HCS	WGUIDE-2.0	FDA UDI	Class I	Active
4.0 VA Locking Screw	TRXV4.0-55 T	FDA UDI	Class II	Active
Pin Plates	RCP3	FDA UDI	Class II	Active
Posterior Malleolar Plates	PMLB 5-3	FDA UDI	Class II	Active
SmallThreadedIMNail 2.1mm (sst)	IMN2.1-45 S	FDA UDI	Class II	Active
HeadCannCompScrew 7.3mm	HS7364	FDA UDI	Class II	Active
4.0 VA Locking Screw	TRXV4.0-28 T	FDA UDI	Class II	Active
Torx Cortical Screw	TRX2.3-24	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3529	FDA UDI	Class II	Active
Torx 2.4 Cortical Screw	TRX2.4-07	FDA UDI	Class II	Active
HeadCannCompScrew 3.0mm	HL3013	FDA UDI	Class II	Active
Washers	AFSW	FDA UDI	Class II	Active
Locking HEX Screw 3.2mm	LHEX3.2-17	FDA UDI	Class II	Active
2.3 Cortical Screw	TRXC2.3-06 T	FDA UDI	Class II	Active
Tools - WS3	WS3-SCREW	FDA UDI	Class I	Active
Tools - LHD	LHD-SCREW4.5	FDA UDI	Class I	Active
Torx Smooth Peg 2.3mm	SPEG2.3-26	FDA UDI	Class II	Active
HPS Cortical Screw 1.8mm	PHCS1.8-06	FDA UDI	Class II	Active
Hand Plates	MMT-6N	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3533	FDA UDI	Class II	Active
S.A. - Hook Plates	HOOKL-6	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.