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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 17 of 60

Device	Model / Reference	Registries	Class	Status
Drills	DRILL-1.2/085	FDA UDI	Class I	Active
Tools - UFC	FCTRAY	FDA UDI	Class I	Active
2.7 Cortical Screw	TRXC2.7-14 T	FDA UDI	Class II	Active
Tools - Screws	TXDRIVR-8	FDA UDI	Class I	Active
Tools - EFS	OHKGUIDE	FDA UDI	Class I	Active
Peg Plates	RPGR-10	FDA UDI	Class II	Active
CannCompScrew 3.5mm (SelfDrill)	L3542	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	L3029	FDA UDI	Class II	Active
Crosslock Screw	XLS3.4-44	FDA UDI	Class II	Active
Tools - FPS	GUIDEFPS-2.0/2.7	FDA UDI	Class I	Active
FPS Locking Screw 2.0mm	CLS2.0-14	FDA UDI	Class II	Active
Drills	DRILL-5.1/220C	FDA UDI	Class I	Active
Tools - FPS	BNDROD-L	FDA UDI	Class I	Active
Hook Plates	OHOOKL-8	FDA UDI	Class II	Active
HeadCannCompScrew 3.0mm	HL3009	FDA UDI	Class II	Active
Cancellous Screw 3.8mm	CAB3.8-24	FDA UDI	Class II	Active
Tools - CFS	CFS-PLATE	FDA UDI	Class I	Active
Volar Peg Unthreaded	VPG-U-24	FDA UDI	Class II	Active
CannCompScrew 2.3mm (sst)	L2316 S	FDA UDI	Class II	Active
CannCompScrew 5.5mm (SelfDrill)	L5544	FDA UDI	Class II	Active
Tools - FPS	BNDROD-2.7/3.5/4.0	FDA UDI	Class I	Active
3.5 Cortical Screw	HEXC3.5-36 T	FDA UDI	Class II	Active
Tools - WFS (C)	BRT (C)	FDA UDI	Class I	Active
HPS Cortical Screw 1.5mm	PHCS1.5-07	FDA UDI	Class II	Active
2.3 Cortical Screw	TRXC2.3-26 T	FDA UDI	Class II	Active
Drills	DRILL-6.0/220C	FDA UDI	Class I	Unknown
SmallThreadedIMNail 1.8mm (sst)	IMN1.8-26 S	FDA UDI	Class II	Active
Torx 2.4 Unthreaded Peg	UPEG2.4-12	FDA UDI	Class II	Active
Saw Blades	OSB-LM	FDA UDI	Class I	Active
2.7 VA Locking Screw	HEXV2.7-48 T	FDA UDI	Class II	Active
Tools - Screws	DVHX-3.5/130C TL	FDA UDI	Class I	Active
SmallThreadedIMNail 2.1mm (sst)	IMN2.1-30 S	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3513	FDA UDI	Class II	Active
Locking Cortical Screw 2.7mm	LCBS2.7-40	FDA UDI	Class II	Active
SmallThreadedIMNail 2.7mm (Ti)	IMN2.7-50 T	FDA UDI	Class II	Active
Foot Plates	MCFR-6	FDA UDI	Class II	Active
Volar Fixed Angle Plates	VFPL-3-7N	FDA UDI	Class II	Active
Lag Screw 3.2mm	LAG3.2-12	FDA UDI	Class II	Active
CannCompScrew 1.7mm (sst)	L1710 S	FDA UDI	Class II	Active
Crosslock Screw	XLS3.4-54	FDA UDI	Class II	Active
Generic Instruments	BNDPLT-CFS	FDA UDI	Class I	Active
2.7 Cortical Screw	HEXC2.7-42 T	FDA UDI	Class II	Active
2.7 Cortical Screw	TRXC2.7-08 T	FDA UDI	Class II	Active
HeadCannCompScrew 1.7mm	HL1711	FDA UDI	Class II	Active
CannCompScrew 7.3mm (Classic)	CL7364	FDA UDI	Class II	Active
Volar Fixed Angle Plates	VFPR-5-7N	FDA UDI	Class II	Active
FPS Non-Locking Screw 3.5mm	CNS3.5-32	FDA UDI	Class II	Active
CannCompScrew 1.7mm (SelfDrill)	L1714	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	L3024	FDA UDI	Class II	Active
Sleds	MPP-WIRE	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.