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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 43 of 60

Device	Model / Reference	Registries	Class	Status
Torx Cortical Screw	TRX2.3-30	FDA UDI	Class II	Active
Drills	DRILL-1.8/100C S	FDA UDI	Class I	Active
HeadCannCompScrew 7.3mm	HS7376	FDA UDI	Class II	Active
Torx 2.4 Threaded Peg	TPEG2.4-20	FDA UDI	Class II	Active
Drills	DRILL-2.4/120C	FDA UDI	Class I	Active
Foot Plates	MFS-2S	FDA UDI	Class II	Active
HeadCannCompScrew 3.0mm	HL3011	FDA UDI	Class II	Active
Foot Plates	MFS-6	FDA UDI	Class II	Active
Torx 2.4 Threaded Peg	TPEG2.4-28	FDA UDI	Class II	Active
3.5 Locking Screw	HEXL3.5-42 T	FDA UDI	Class II	Active
Nail Peg	IPEG3.2-22	FDA UDI	Class II	Active
2.7 Locking Screw	HEXL2.7-46 T	FDA UDI	Class II	Active
Clavicle Plates	CPSLATR-11	FDA UDI	Class II	Active
Foot Plates	FFOYA-6	FDA UDI	Class II	Active
Tools - HPS	HPS-TRAY	FDA UDI	Class I	Active
Pin Plates	RPIN-5	FDA UDI	Class II	Active
Torx Unthreaded Peg	UPEG-22	FDA UDI	Class II	Active
Drills	DRILL-1.8	FDA UDI	Class I	Active
Tools - AFS	MMSLEDW-GUIDE (O)	FDA UDI	Class I	Active
Foot Plates	XP35-M	FDA UDI	Class II	Active
3.5 Cortical Screw	HEXC3.5-14 T	FDA UDI	Class II	Active
SmallThreadedIMNail 3.0mm (sst)	IMN3.0-35 S	FDA UDI	Class II	Active
CannCompScrew 5.5mm (SelfDrill)	L5572	FDA UDI	Class II	Active
Locking Cortical Screw 3.2mm	LCBS3.2-26	FDA UDI	Class II	Active
HPS Cortical Screw 1.8mm	PHCS1.8-10	FDA UDI	Class II	Active
CannCompScrew 3.5mm (SelfDrill)	L3536	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3520	FDA UDI	Class II	Active
HeadCannCompScrew 1.7mm	HL1710	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	L3030	FDA UDI	Class II	Active
Nail Peg	IPEG3.2-24	FDA UDI	Class II	Active
SmallThreadedIMNail 1.8 (Ti)	IMN1.8-36 T	FDA UDI	Class II	Active
Drills	DRILL-3.2/220C	FDA UDI	Class I	Active
Volar Peg Unthreaded	VPG-U-28	FDA UDI	Class II	Active
Cortical Screws 2.3mm	CBS2.3-24	FDA UDI	Class II	Active
Tools - Screws	DVHX-2.5/110N AO	FDA UDI	Class I	Active
K-Wires	WIRE-1.1/150	FDA UDI	Class II	Active
Lag Screw 3.2mm	LAG3.2-26	FDA UDI	Class II	Active
Tools - AFS	MPP-INSERTR	FDA UDI	Class I	Active
Tools - WFS	XPANDR-BRKT	FDA UDI	Class I	Active
Tools - WFS	MINI-GUIDE	FDA UDI	Class I	Active
Cortical Screws 2.3mm	CBS2.3-30	FDA UDI	Class II	Active
CannCompScrew 3.0mm (sst)	L3020 S	FDA UDI	Class II	Active
2.7 Locking Screw	HEXL2.7-14 T	FDA UDI	Class II	Active
Drills	DRILL-2.0/110TSA	FDA UDI	Class I	Active
Hex Cortical Screw 3.2mm	HEX3.2-08	FDA UDI	Class II	Active
Torx Threaded Peg	TPEG-30	FDA UDI	Class II	Active
2.7 VA Locking Screw	HEXV2.7-24 T	FDA UDI	Class II	Active
CannCompScrew 3.5mm (sst)	L3526 S	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3514	FDA UDI	Class II	Active
Torx Cortical Screw	TRX2.3-27	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.