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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 10 of 60

Device	Model / Reference	Registries	Class	Status
4.0 VA Locking Screw	TRXV4.0-50 T	FDA UDI	Class II	Active
CannCompScrew 4.5mm (Classic)	C4530	FDA UDI	Class II	Active
Drills	JDRILL-1.2/085	FDA UDI	Class I	Active
Tools - AFS	AFS-TRAY-LID	FDA UDI	Class I	Active
2.7 Cortical Screw	HEXC2.7-12 T	FDA UDI	Class II	Active
Tools - SSS	SSS-TRAY-LID	FDA UDI	Class I	Active
CannCompScrew 3.0mm (SelfDrill)	S3035	FDA UDI	Class II	Active
Drills	DRILL-2.3/130 M	FDA UDI	Class I	Active
Tools - UOS	CD-GUIDE	FDA UDI	Class I	Active
Osteotomy Compression Plates	UOCP-S	FDA UDI	Class II	Active
Drills	SDRILL-2.1C	FDA UDI	Class I	Active
Hook Plates	WHKD-4	FDA UDI	Class II	Active
Tools - UOS	UOSG-B	FDA UDI	Class I	Active
Tools- HCS	MOSG-SLIDE	FDA UDI	Class I	Active
CannCompScrew 5.5mm (SelfDrill)	S5552	FDA UDI	Class II	Active
Tools - WFS	GDWHV-1.8	FDA UDI	Class I	Active
Tools - Screws	HXDRIVR-2.0C AO	FDA UDI	Class I	Active
CannCompScrew 7.3mm (SelfDrill)	S7380	FDA UDI	Class II	Active
Foot Plates	EOW8-4	FDA UDI	Class II	Active
Tools - LHS	LHS-SCREW7.3-LID	FDA UDI	Class I	Active
Torx Unthreaded Peg	UPEG-24	FDA UDI	Class II	Active
CLASSIC Radial Column Pin Plate	RPP7	FDA UDI	Class II	Active
Tools - HPS	MCVGUIDE-1.6	FDA UDI	Class I	Active
SideWinder Fracture Plates	SWOR-6N	FDA UDI	Class II	Active
Tools - Screws	HXDRIVR-3.0CL AO	FDA UDI	Class I	Active
Hex Cortical Screw 3.2mm	HEX3.2-26	FDA UDI	Class II	Active
CannCompScrew 3.5mm (sst)	L3520 S	FDA UDI	Class II	Active
Drills	DRILL-3.5/110TSA	FDA UDI	Class I	Active
FPS Locking Screw 3.0mm	CLS3.0-16	FDA UDI	Class II	Active
CannCompScrew 5.5mm (SelfDrill)	S5556	FDA UDI	Class II	Active
CannCompScrew 2.3mm (SelfDrill)	L2312	FDA UDI	Class II	Active
2.7 Locking Screw	TRXL2.7-18 T	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	L3031	FDA UDI	Class II	Active
Cortical Screws 2.3mm	CBS2.3-22	FDA UDI	Class II	Active
4.0 VA Locking Screw	TRXV4.0-16 T	FDA UDI	Class II	Active
Locking Plates	PCB15	FDA UDI	Class II	Active
Drills	DRILL-1.5/095C	FDA UDI	Class I	Active
Tools - CFS	CFS-SCREW-LID	FDA UDI	Class I	Active
HeadCannCompScrew 3.5mm	HL3544	FDA UDI	Class II	Active
CannCompScrew 2.0mm (SelfDrill)	L2019	FDA UDI	Class II	Active
2.7 Locking Screw	HEXL2.7-24 T	FDA UDI	Class II	Active
SmallThreadedIMNail 2.7mm (sst)	IMN2.7-55 S	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3543	FDA UDI	Class II	Active
HeadCannCompScrew 5.5mm	HS5534	FDA UDI	Class II	Active
SideWinder Fracture Plates	SWOR-7M	FDA UDI	Class II	Active
Sleds	MMSLED-60	FDA UDI	Class II	Active
Volar Bearing Plates	VLBPL-5-5	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3526	FDA UDI	Class II	Active
Tools - Screws	GUIDE-2.3/3.2	FDA UDI	Class I	Active
CannCompScrew 3.5mm (Classic)	C3535	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.