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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 5 of 60

Device	Model / Reference	Registries	Class	Status
4.0 Cortical Screw	TRXC4.0-14 T	FDA UDI	Class II	Active
Tools - FPS	RMRFPS-18	FDA UDI	Class I	Active
3.5 Locking Screw	HEXL3.5-14 T	FDA UDI	Class II	Active
Drills	DRILL-3.5/130	FDA UDI	Class I	Active
Tools - AFS	CLS-PLATE-LID	FDA UDI	Class I	Active
FPS Non-Locking Screw 3.5mm	CNS3.5-26	FDA UDI	Class II	Active
3.5 VA Locking Screw	TRXV3.5-20 T	FDA UDI	Class II	Active
Tools - HCS	ELEV-SSS	FDA UDI	Class I	Active
Hex Cortical Screw 3.2mm	HEX3.2-27	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	L3019	FDA UDI	Class II	Active
2.3 VA Locking Screw	TRXV2.3-08 T	FDA UDI	Class II	Active
Cortical Screws 3.2mm	CBS3.2-16	FDA UDI	Class II	Active
Tools - WS3	GDBLOCK-SR	FDA UDI	Class I	Active
2.7 Locking Screw	TRXL2.7-14 T	FDA UDI	Class II	Active
Tools - FPS	RMRFPS-20	FDA UDI	Class I	Active
Hook Plates	OHOOK-4	FDA UDI	Class II	Active
Foot Plates	MCFR-12L	FDA UDI	Class II	Active
Locking HEX Screw 3.2mm	LHEX3.2-25	FDA UDI	Class II	Active
SmallThreadedIMNail 3.0mm (sst)	IMN3.0-30 S	FDA UDI	Class II	Active
Foot Plates	MTP10R-6	FDA UDI	Class II	Active
Locking HEX Screw 3.2mm	LHEX3.2-29	FDA UDI	Class II	Active
CannCompScrew 2.3mm (SelfDrill)	L2322	FDA UDI	Class II	Active
Tools - AFS	CLS-PLATE	FDA UDI	Class I	Active
HPS Locking Screw 1.5mm	PHLS1.5-09	FDA UDI	Class II	Active
FPS Locking Screw 3.5mm	CLS3.5-28	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-41	FDA UDI	Class II	Active
S.A. - Clavicle Plates	CPA-MID-10	FDA UDI	Class II	Active
3.5 VA Locking Screw	HEXV3.5-44 T	FDA UDI	Class II	Active
Foot Plates	MFU-12	FDA UDI	Class II	Active
Tools - WFS	WFS-SCREW	FDA UDI	Class I	Active
HeadCannCompScrew 4.5mm	HS4538	FDA UDI	Class II	Active
Posterior Malleolar Plates	PMLB-6-4	FDA UDI	Class II	Active
Tools - HCS	HCS-SCREW3.0-LID	FDA UDI	Class I	Active
HeadCannCompScrew 3.5mm	HL3519	FDA UDI	Class II	Active
S.A. - Clavicle Plates	CPS-DISL-14	FDA UDI	Class II	Active
2.3 Locking Screw	TRXL2.3-28 T	FDA UDI	Class II	Active
Elastic Staples	ES-10x17	FDA UDI	Class II	Active
Tools - Screws	GUIDELB-1.8NW	FDA UDI	Class I	Active
3.5 Cortical Screw	HEXC3.5-20 T	FDA UDI	Class II	Active
Elastic Staples	ES-12x16x19	FDA UDI	Class II	Active
Torx 2.4 Unthreaded Peg	UPEG2.4-32	FDA UDI	Class II	Active
2.7 Cortical Screw	HEXC2.7-55 T	FDA UDI	Class II	Active
Tools-Screws	DVHX-1.6/070MC AO	FDA UDI	Class I	Active
Pin Plates	DPIN-3	FDA UDI	Class II	Active
HeadCannCompScrew 7.3mm	HL7368	FDA UDI	Class II	Active
Volar Bearing Plates	VLBPR-3-7N	FDA UDI	Class II	Active
3.5 Cortical Screw	HEXC3.5-55 T	FDA UDI	Class II	Active
Hand Plates	MMT-10N	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3534	FDA UDI	Class II	Active
SmallThreadedIMNail 1.8mm (sst)	IMN1.8-16 S	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.