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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 23 of 60

Device	Model / Reference	Registries	Class	Status
Elastic Staples	ES-18x17x19	FDA UDI	Class II	Active
Hook Plates	OHOOKL-13	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3541	FDA UDI	Class II	Active
2.7 Cortical Screw	HEXC2.7-32 T	FDA UDI	Class II	Active
SmallThreadedIMNail 3.0mm (sst)	IMN3.0-60 S	FDA UDI	Class II	Active
2.7 Locking Screw	HEXL2.7-08 T	FDA UDI	Class II	Active
Drills	DRILL-3.20L	FDA UDI	Class I	Active
Tools - AFS	AFS-SCREW-LID	FDA UDI	Class I	Active
Posterior Malleolar Plates	PMLA-3-3	FDA UDI	Class II	Active
3.5 Locking Screw	HEXL3.5-24 T	FDA UDI	Class II	Active
Locking Cortical Screw 3.2mm	LCBS3.2-50	FDA UDI	Class II	Active
Tools - TSS	IMPCT-STPL	FDA UDI	Class I	Active
Torx Smooth Peg 2.3mm	SPEG2.3-40	FDA UDI	Class II	Active
Posterior Malleolar Plates	PMT 3-3	FDA UDI	Class II	Active
Locking HEX Screw 3.2mm	LHEX3.2-22	FDA UDI	Class II	Active
Tools - WFS	WIRCUTR	FDA UDI	Class I	Active
Foot Plates	LAPR-7	FDA UDI	Class II	Active
Foot Plates	UHP-5	FDA UDI	Class II	Active
Tools - LHS	LHSCADDY-5.5	FDA UDI	Class I	Active
Foot Plates	MCFR-12	FDA UDI	Class II	Active
Tools - AFS	AFS-TIB	FDA UDI	Class I	Active
Locking Plates	SMTP-3	FDA UDI	Class II	Active
HeadCannCompScrew 3.5mm	HL3542	FDA UDI	Class II	Active
Volar Fixed Angle Plates	VFPL-7-7N	FDA UDI	Class II	Active
Elastic Staples	ES-12x10	FDA UDI	Class II	Active
CannCompScrew 3.5mm (SelfDrill)	L3517	FDA UDI	Class II	Active
CannCompScrew 7.3mm (Classic)	C7350	FDA UDI	Class II	Active
Torx Unthreaded Peg	UPEG-16	FDA UDI	Class II	Active
Volar Peg Unthreaded	VPG-U-22	FDA UDI	Class II	Active
HeadCannCompScrew 5.5mm	HS5542	FDA UDI	Class II	Active
3.5 Cortical Screw	HEXC3.5-46 T	FDA UDI	Class II	Active
Tools - FMS	GDMHOOK-1.8	FDA UDI	Class I	Active
Torx Unthreaded Peg	UPEG-18	FDA UDI	Class II	Active
Hand Plates	PHBR-5	FDA UDI	Class II	Active
CannCompScrew 7.3mm (SelfDrill)	S73108	FDA UDI	Class II	Active
Tools - WFS	GAUGE-BRKT	FDA UDI	Class II	Active
Locking HEX Screw 3.2mm	LHEX3.2-09	FDA UDI	Class II	Active
CannCompScrew 7.3mm (SelfDrill)	S7342	FDA UDI	Class II	Active
Drills	DRILL-2.0/130	FDA UDI	Class I	Active
Locking Cortical Screw 2.7mm	LCBS2.7-22	FDA UDI	Class II	Active
HeadCannCompScrew 4.5mm	HS4528	FDA UDI	Class II	Active
3.5 VA Locking Screw	TRXV3.5-14 T	FDA UDI	Class II	Active
Tools - HCS	PUSHR-0.8/220	FDA UDI	Class I	Active
Tools - DHF	BALLWIRE-1.6/380	FDA UDI	Class I	Active
Cortical Screws 3.2mm	CBS3.2-10	FDA UDI	Class II	Active
Tools - WFS	BNDPLT-WFS L	FDA UDI	Class I	Active
Hex Cortical Screw 4.0mm	HEX4.0-55	FDA UDI	Class II	Active
Tools - WFS	IMPCT-WHV	FDA UDI	Class I	Active
Tools - DHF	GDXDH-2.3	FDA UDI	Class I	Active
Tools - UFC	FCHNDL	FDA UDI	Class I	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.