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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 40 of 60

Device	Model / Reference	Registries	Class	Status
Tools - ROS	ROS-CADDY-LID	FDA UDI	Class I	Active
CannCompScrew 4.5mm (SelfDrill)	L4560	FDA UDI	Class II	Active
Tools - WFS	PLTBNDR-L	FDA UDI	Class I	Active
HeadCannCompScrew 4.0mm	CCS4.0-55	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-21	FDA UDI	Class II	Active
Tools - AFS	GDMMSLEDW-2.3	FDA UDI	Class I	Active
Tools - FPS	GDLAPHR-1.8	FDA UDI	Class I	Active
Elastic Staples	ES-18x12	FDA UDI	Class II	Active
2.3 Locking Screw	TRXL2.3-32 T	FDA UDI	Class II	Active
Generic Instruments	BNDR	FDA UDI	Class I	Active
Tools - SHD	SHD-TRAY-LID	FDA UDI	Class I	Active
CannCompScrew 3.0mm (sst)	L3023 S	FDA UDI	Class II	Active
Foot Plates	FFS-2	FDA UDI	Class II	Active
CannCompScrew 7.3mm (SelfDrill)	S73112	FDA UDI	Class II	Active
3.5 Cortical Screw	TRXC3.5-44 T	FDA UDI	Class II	Active
2.7 VA Locking Screw	HEXV2.7-18 T	FDA UDI	Class II	Active
Tools - HCS	CANNULA-2.0	FDA UDI	Class I	Active
2.7 VA Locking Screw	TRXV2.7-14 T	FDA UDI	Class II	Active
Locking HEX Screw 3.2mm	LHEX3.2-10	FDA UDI	Class II	Active
Drills	DRILL-4.8/220C	FDA UDI	Class I	Active
Volar Bearing Plates	VBEAL-3-7S	FDA UDI	Class II	Active
Tools-INS	RMVIMN-3.0/3.6	FDA UDI	Class I	Active
Tools - Screws	DVHX-2.0/140 AO	FDA UDI	Class I	Active
Foot Plates	FFS-3	FDA UDI	Class II	Active
Foot Plates	MMTP5L-6	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	S3015	FDA UDI	Class II	Active
Pin Plates	DUP5	FDA UDI	Class II	Active
Foot Plates	CSOP10-6	FDA UDI	Class II	Active
Volar Bearing Plates	VBEAL-5-7W	FDA UDI	Class II	Active
Locking Cortical Screw 3.2mm	LCBS3.2-22	FDA UDI	Class II	Active
FMS Screw 4.5mm	JHEX4550	FDA UDI	Class II	Active
Cancellous Screws 6.5mm	CAB6.5-30	FDA UDI	Class II	Active
HPS Locking Screw 2.0mm	MCLS2.0-20	FDA UDI	Class II	Active
Locking Compression Screw 2.4mm	NC2422	FDA UDI	Class II	Active
Lag Screw 3.2mm	LAG3.2-16	FDA UDI	Class II	Active
Tools - WFS	IMPACTR	FDA UDI	Class I	Active
Tools - Screws	QGUIDE-1.8	FDA UDI	Class I	Active
FMS Screw 4.5mm	JHEX4540	FDA UDI	Class II	Active
Hex Cortical Screw 2.7mm	HEX2.7-45	FDA UDI	Class II	Active
Pin Plates	DUP3	FDA UDI	Class II	Active
Crosslock Screw	XLS3.4-68	FDA UDI	Class II	Active
CannCompScrew 5.5mm (SelfDrill)	S5530	FDA UDI	Class II	Active
HPS Locking Screw 2.0mm	MCLS2.0-14	FDA UDI	Class II	Active
CannCompScrew 1.7mm (Classic)	C1713	FDA UDI	Class II	Active
Tools-Screws	DVTX-8/110 AO B	FDA UDI	Class I	Active
3.5 Cortical Screw	TRXC3.5-60 T	FDA UDI	Class II	Active
Tools - FPS	UHP-4 T	FDA UDI	Class I	Active
Tools - WFS	WHV-IMPACTR	FDA UDI	Class I	Active
CannCompScrew 7.3mm (SelfDrill)	S7376	FDA UDI	Class II	Active
3.5 Locking Screw	HEXL3.5-18 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.