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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 54 of 60

Device	Model / Reference	Registries	Class	Status
Distal Humerus Plates	HSMNPR-3	FDA UDI	Class II	Active
CannCompScrew 4.5mm (SelfDrill)	S4538	FDA UDI	Class II	Active
Volar Bearing Plates	VLBPR-11-7	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	L3013	FDA UDI	Class II	Active
Tools - Screws	GUIDELCBS-2.3	FDA UDI	Class I	Active
Locking Cortical Screw 3.2mm	LCBS3.2-24	FDA UDI	Class II	Active
Locking Plates	SMTP-8	FDA UDI	Class II	Active
Elastic Staples	ES-12x13x15	FDA UDI	Class II	Active
Tools - WS3	WS3-VOLARB-LID	FDA UDI	Class I	Active
HPS Locking Screw 1.5mm	PHLS1.5-17	FDA UDI	Class II	Active
Generic Instruments	TACPLT-1.6/065 T	FDA UDI	Class I	Active
Torx 2.4 Unthreaded Peg	UPEG2.4-18	FDA UDI	Class II	Active
Tools - HCS	HCS-SCREW2.0	FDA UDI	Class I	Active
Tools - HPS	HPS-CADDY2.0	FDA UDI	Class I	Active
2.3 Locking Screw	TRXL2.3-06 T	FDA UDI	Class II	Active
Locking Compression Screw 2.4mm	NC2418	FDA UDI	Class II	Active
SmallThreadedIMNail 1.8mm (sst)	IMN1.8-22 S	FDA UDI	Class II	Active
SmallThreadedIMNail 3.0mm (sst)	IMN3.0-70 S	FDA UDI	Class II	Active
Torx Unthreaded Peg	UPEG-14	FDA UDI	Class II	Active
K-Wires	WIRE-1.6/150	FDA UDI	Class II	Active
HeadCannCompScrew 5.5mm	HS5530	FDA UDI	Class II	Active
CannCompScrew 4.5mm (SelfDrill)	L4552	FDA UDI	Class II	Active
Tools - FPS	RMRFPSC-22	FDA UDI	Class I	Active
HeadCannCompScrew 7.3mm	HS7352	FDA UDI	Class II	Active
FPS Locking Screw 2.3mm	CLS2.3-14	FDA UDI	Class II	Active
Tools - HPS	CSINK-1.2/1.5	FDA UDI	Class I	Active
Tools - Screws	HXDRIVR-1.5C AO	FDA UDI	Class I	Active
HeadCannCompScrew 7.3mm	HL73100	FDA UDI	Class II	Active
4.0 VA Locking Screw	TRXV4.0-18 T	FDA UDI	Class II	Active
SmallThreadedIMNail 1.8mm (Ti)	IMN1.8-50 T	FDA UDI	Class II	Active
SmallThreadedIMNail 2.1mm (sst)	IMN2.1-60 S	FDA UDI	Class II	Active
2.3 VA Locking Screw	TRXV2.3-26 T	FDA UDI	Class II	Active
Tools - SFC	RMRSFC-17	FDA UDI	Class I	Active
Tools - LHS	GUIDE-10	FDA UDI	Class I	Active
CannCompScrew 3.0mm (SelfDrill)	S3026	FDA UDI	Class II	Active
CannCompScrew 4.5mm (Classic)	C4538	FDA UDI	Class II	Active
CannCompScrew 3.5mm (SelfDrill)	L3531	FDA UDI	Class II	Active
SmallThreadedIMNail 3.6mm (Ti)	IMN3.6-55 T	FDA UDI	Class II	Active
SmallThreadedIMNail 2.4mm (sst)	IMN2.4-50 S	FDA UDI	Class II	Active
2.3 VA Locking Screw	TRXV2.3-16 T	FDA UDI	Class II	Active
CannCompScrew 2.0mm (SelfDrill)	L2023	FDA UDI	Class II	Active
CannCompScrew 2.0mm (SelfDrill)	L2011	FDA UDI	Class II	Active
Drills	DRILL-2.1/100C S	FDA UDI	Class I	Active
SmallThreadedIMNail 1.8mm (sst)	IMN1.8-24 S	FDA UDI	Class II	Active
SmallThreadedIMNail 3.6mm (Ti)	IMN3.6-40 T	FDA UDI	Class II	Active
CannCompScrew 3.5mm (SelfDrill)	L3519	FDA UDI	Class II	Active
S.A. - Volar Bearing Plates	VLBPR-15-4	FDA UDI	Class II	Active
K-Wires	WIRE-2.5/230	FDA UDI	Class II	Active
4.0 VA Locking Screw	TRXV4.0-08 T	FDA UDI	Class II	Active
Fusion Cups	FC10	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.