Is this your brand? Sign in to claim ownership.

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 57 of 60

Device	Model / Reference	Registries	Class	Status
Tools - WFS (C)	TAP-2.3	FDA UDI	Class I	Active
FPS Locking Screw 3.5mm	CLS3.5-12	FDA UDI	Class II	Active
CannCompScrew 2.3mm (SelfDrill)	L2327	FDA UDI	Class II	Active
Torx Unthreaded Peg	UPEG-20	FDA UDI	Class II	Active
Snap-off Screw 1.6mm	SNP1.6-18	FDA UDI	Class II	Active
CannCompScrew 7.3mm (SelfDrill)	S73104	FDA UDI	Class II	Active
Cortical Screws 2.3mm	CBS2.3-26	FDA UDI	Class II	Active
Tools - FPS	LAPHL-5 T	FDA UDI	Class I	Active
Tools - HCS	SCPHELE	FDA UDI	Class I	Active
S.A. - Volar Bearing Plates	VLBPR-10-4	FDA UDI	Class II	Active
Cancellous Screw 3.8mm	CAB3.8-10	FDA UDI	Class II	Active
2.7 VA Locking Screw	TRXV2.7-08 T	FDA UDI	Class II	Active
FPS Locking Screw 2.7mm	CLS2.7-20	FDA UDI	Class II	Active
Tools - WS3	WS3-VOLAR	FDA UDI	Class I	Active
HeadCannCompScrew 2.3mm	HL2309	FDA UDI	Class II	Active
Tools - LHS	LHS-TRAY-LID	FDA UDI	Class I	Active
Tools - CFS	GUIDELCBS-2.3 NW	FDA UDI	Class I	Active
S.A. - Volar Bearing Plates	VLBPL-7-4	FDA UDI	Class II	Active
Hand Plates	PHLR-5	FDA UDI	Class II	Active
CannCompScrew 3.5mm (sst)	L3522 S	FDA UDI	Class II	Active
SmallThreadedIMNail 2.7mm (sst)	IMN2.7-45 S	FDA UDI	Class II	Active
Tools - DHF	SLVGDI-2.3/060	FDA UDI	Class I	Unknown
Generic Instruments	BNDPLT-AFS	FDA UDI	Class I	Active
Elastic Staples	ES-15x13x16	FDA UDI	Class II	Active
Tools - FPS	FPS-RER	FDA UDI	Class I	Active
Tools - EFS	EFS-PLATE--LID	FDA UDI	Class I	Active
Tools - DHF	SLVGDI-2.3	FDA UDI	Class I	Active
HPS Cortical Screw 1.2mm	PHCS1.2-05	FDA UDI	Class II	Active
HPS Cortical Screw 1.5mm	PHCS1.5-08	FDA UDI	Class II	Active
HeadCannCompScrew 7.3mm	HS7348	FDA UDI	Class II	Active
CannCompScrew 3.0mm (SelfDrill)	L3035	FDA UDI	Class II	Active
4.0 VA Locking Screw	TRXV4.0-20 T	FDA UDI	Class II	Active
S.A. - Clavicle Plates	CPA-LAT-7	FDA UDI	Class II	Active
3.5 VA Locking Screw	HEXV3.5-48 T	FDA UDI	Class II	Active
Tools - Screws	TAP-3.2 AO	FDA UDI	Class I	Active
CannCompScrew 3.0mm (SelfDrill)	L3039	FDA UDI	Class II	Active
CannCompScrew 2.0mm (SelfDrill)	L2008	FDA UDI	Class II	Active
S.A. - Clavicle Plates	CPS-MIDR-8L	FDA UDI	Class II	Active
Tools - WS3	GDMINI-1.8	FDA UDI	Class I	Active
Tools - HCS	PUSHR-1.1/220	FDA UDI	Class I	Active
Tools - EFS	GDOHOOK-2.3	FDA UDI	Class I	Active
CannCompScrew 2.3mm (Classic)	C2318	FDA UDI	Class II	Active
HeadCannCompScrew 3.0mm	HL3031	FDA UDI	Class II	Active
3.5 VA Locking Screw	TRXV3.5-55 T	FDA UDI	Class II	Active
Drills	DRILL-5.0/200C	FDA UDI	Class I	Active
SmallThreadedIMNail 2.4mm (sst)	IMN2.4-65 S	FDA UDI	Class II	Active
CannCompScrew 3.5mm (Classic)	C3545	FDA UDI	Class II	Active
Tools - FPS	BNDRODL-2.7/3.5	FDA UDI	Class I	Active
Drills	DRILL-2.00CL	FDA UDI	Class I	Active
Tools-INS	RMVIMN-2.4/2.7	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.