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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 9 of 60

Device	Model / Reference	Registries	Class	Status
CannCompScrew 3.0mm (sst)	L3010 S	FDA UDI	Class II	Active
HeadCannCompScrew 2.3mm	HL2315	FDA UDI	Class II	Active
Volar Peg Threaded	VPG-T-20	FDA UDI	Class II	Active
SmallThreadedIMNail 2.4mm (sst)	IMN2.4-35 S	FDA UDI	Class II	Active
Foot Plates	LFR-8S	FDA UDI	Class II	Active
HPS Locking Screw 1.5mm	PHLS1.5-04	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	S3025	FDA UDI	Class II	Active
Tools - FPS	GDUHPW-1.8	FDA UDI	Class I	Active
Hand Plates	MMLR-6	FDA UDI	Class II	Active
Locking Cortical Screw 2.7mm	LCBS2.7-26	FDA UDI	Class II	Active
CannCompScrew 7.3mm (Classic)	C7388	FDA UDI	Class II	Active
Cortical Screws 3.2mm	CBS3.2-14	FDA UDI	Class II	Active
Tools - Screws	DVHX-2.0/110 AO	FDA UDI	Class I	Active
Locking Cortical Screw 2.7mm	LCBS2.7-18	FDA UDI	Class II	Active
Generic Instruments	GAUGWIR-2.5/230	FDA UDI	Class I	Active
Tools - Screws	GUIDE-2.0/2.7	FDA UDI	Class I	Active
Tools - HCS	HCS-SCREW3.0	FDA UDI	Class I	Active
Hex Cortical Screw 2.7mm	HEX2.7-34	FDA UDI	Class II	Active
Tools - FPS	COMPR-1.6/2.5	FDA UDI	Class I	Active
Foot Plates	TP27-9	FDA UDI	Class II	Active
Calcaneal Plates	CLSR-07	FDA UDI	Class II	Active
HeadCannCompScrew 5.5mm	HS5548	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	L3015	FDA UDI	Class II	Active
Tools - EFS	EFS-TRAY-LID	FDA UDI	Class I	Active
CannCompScrew 2.3mm (sst)	L2320 S	FDA UDI	Class II	Active
CannCompScrew 3.0mm (Classic)	C3014	FDA UDI	Class II	Active
Foot Plates	ECP35	FDA UDI	Class II	Active
Tools - AFS	AFS-SWO (O)	FDA UDI	Class I	Active
Tools - EFS	EFS-PLATE	FDA UDI	Class I	Active
Foot Plates	FFH-4	FDA UDI	Class II	Active
Locking Cortical Screw 2.7mm	LCBS2.7-12	FDA UDI	Class II	Active
Tools - CFF	BNDCLP-CFF	FDA UDI	Class I	Active
CannCompScrew 3.0mm (SelfDrill)	L3018	FDA UDI	Class II	Active
Locking Plates	CLST-12-6	FDA UDI	Class II	Active
Tools-INS	RMVIMN-3.0	FDA UDI	Class I	Active
Torx Smooth Peg 2.3mm	SPEG2.3-44	FDA UDI	Class II	Active
Tools - Screws	GUIDELHEX-2.3	FDA UDI	Class I	Active
SmallThreadedIMNail 2.7mm (Ti)	IMN2.7-55 T	FDA UDI	Class II	Active
CannCompScrew 3.0mm (sst)	L3016 S	FDA UDI	Class II	Active
Radial Shortening Plate	RSOPL-4-4	FDA UDI	Class II	Active
HeadCannCompScrew 2.3mm	HL2313	FDA UDI	Class II	Active
S.A. - Volar Bearing Plates	VLBPR-5-4	FDA UDI	Class II	Active
2.7 Cortical Screw	TRXC2.7-30 T	FDA UDI	Class II	Active
Cann. Hex Cortical Screw 3.2mm	HEX3.2C-14	FDA UDI	Class II	Active
CannCompScrew 2.3mm (SelfDrill)	L2310	FDA UDI	Class II	Active
Tools - WFS (C)	DRIVR-3.2	FDA UDI	Class I	Active
Torx 2.4 Unthreaded Peg	UPEG2.4-14	FDA UDI	Class II	Active
Tools - UOS	UOS-LARGE-LID	FDA UDI	Class I	Active
2.7 VA Locking Screw	TRXV2.7-44 T	FDA UDI	Class II	Unknown
Distal Humerus Fixation System	GWDH-1.6	FDA UDI	Class I	Unknown

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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.