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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 29 of 60

Device	Model / Reference	Registries	Class	Status
Cancellous Screws 6.5mm	CAB6.5-26	FDA UDI	Class II	Active
Generic Instruments	QUICK-HNDL-S	FDA UDI	Class I	Active
Clavicle Plates	CPSMIDR-7	FDA UDI	Class II	Active
Tools - LHS	LHSCADDY-4.5	FDA UDI	Class I	Active
Tools - WFS	INSRTR-BRG	FDA UDI	Class I	Active
Tools - HCS	HDSINK-3.5	FDA UDI	Class I	Active
CannCompScrew 7.3mm (Classic)	CL7366	FDA UDI	Class II	Active
Tools - AFS	GDMPP-1.6	FDA UDI	Class I	Active
Locking Plates	PCA8	FDA UDI	Class II	Active
3.5 VA Locking Screw	HEXV3.5-32 T	FDA UDI	Class II	Active
CannCompScrew 2.3mm (SelfDrill)	L2328	FDA UDI	Class II	Active
HeadCannCompScrew 4.0mm	CCS4.0-25	FDA UDI	Class II	Active
Locking Cortical Screw 3.2mm	LCBS3.2-14	FDA UDI	Class II	Active
Hand Plates	PHHR-8	FDA UDI	Class II	Active
Pin Plates	DUP7	FDA UDI	Class II	Active
SmallThreadedIMNail 1.8 (Ti)	IMN1.8-34 T	FDA UDI	Class II	Active
Tools- HCS	MOSG-SCRW	FDA UDI	Class I	Active
3.5 VA Locking Screw	TRXV3.5-24 T	FDA UDI	Class II	Active
3.5 Cortical Screw	HEXC3.5-16 T	FDA UDI	Class II	Active
2.7 Locking Screw	TRXL2.7-08 T	FDA UDI	Class II	Active
Pin Plates	DPIN-7	FDA UDI	Class II	Active
Hex Cortical Screw 3.2mm	HEX3.2-50	FDA UDI	Class II	Active
SmallThreadedIMNail 3.0mm (Ti)	IMN3.0-55 T	FDA UDI	Class II	Active
CannCompScrew 2.0mm (SelfDrill)	L2022	FDA UDI	Class II	Active
Drills	DRILL-4.00L	FDA UDI	Class I	Active
Tools - UOS	UOSG-A-3	FDA UDI	Class I	Active
Tools - HCS	CANNULA-2.3	FDA UDI	Class I	Active
Tools - WFS	PEG-GUIDE-NW	FDA UDI	Class I	Active
CannCompScrew 3.5mm (SelfDrill)	L3545	FDA UDI	Class II	Active
CannCompScrew 7.3mm (Classic)	C7344	FDA UDI	Class II	Active
Tools - Screws	HEX2.5-GRIPR	FDA UDI	Class I	Active
Tools - Screws	GUIDE-1.1/2.1	FDA UDI	Class I	Active
Hand Plates	PHT-8	FDA UDI	Class II	Active
Tools - Screws	GUIDELB-1.8	FDA UDI	Class I	Active
2.3 Locking Screw	TRXL2.3-20 T	FDA UDI	Class II	Active
HPS Cortical Screw 1.2mm	PHCS1.2-12	FDA UDI	Class II	Active
Posterior Malleolar Plates	PMT 5-3	FDA UDI	Class II	Active
Foot Plates	CSP3510	FDA UDI	Class II	Active
Nail Peg	IPEG3.2-14	FDA UDI	Class II	Active
Clavicle Plates	CPSMLTL-8	FDA UDI	Class II	Active
Tools - TWF	TWF-TRAY-LID	FDA UDI	Class I	Active
Torx Cortical Screw	TRX2.3-12	FDA UDI	Class II	Active
Torx Cortical Screw	TRX2.3-31	FDA UDI	Class II	Active
Tools - WFS	BLOCK-L	FDA UDI	Class I	Active
Tools - Screws	HXDRIVR-2.0L AO	FDA UDI	Class I	Active
Volar Bearing Plates	VLBPL-3-7	FDA UDI	Class II	Active
Tools - WFS	GDBLOCK-1.8 SR	FDA UDI	Class I	Active
Generic Instruments	PEG-GUIDE	FDA UDI	Class I	Active
Clavicle Plates	CPSMIDL-7	FDA UDI	Class II	Active
Tools - FPS	SPRDRLMN	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.