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ACUMED LLC

Last updated September 17, 2026

Information

Country: US
Address: 5885 NE Cornelius Pass Rd, Hillsboro, OR, 97124
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000125930
DUNS Number: —

Catalogue (6937)

Page 1 of 139

Device	Model / Reference	Registries	Class	Status
Acumed	30-0219-S	FDA UDI	Class II	Active
Acumed	45-0027-S	FDA UDI	Class I	Active
Acumed	PL-FIB11-S	FDA UDI	Class II	Active
Acumed	FX-4001-S	FDA UDI	Class II	Active
Acumed	ATF-037	FDA UDI	Class I	Active
Acumed	AT2-C09	FDA UDI	Class II	Active
Acumed	CO-F2114	FDA UDI	Class II	Active
Acumed	COL-2120	FDA UDI	Class II	Active
Acumed	80-0809	FDA UDI	Class I	Active
Acumed	80-0619	FDA UDI	Class I	Active
Acumed	3005-65140	FDA UDI	Class II	Active
Acumed	3011-43052	FDA UDI	Class II	Active
Acumed	CA-PHB55	FDA UDI	Class II	Active
Acumed	AT2-C002	FDA UDI	Class I	Active
Acumed	AP-67120-S	FDA UDI	Class II	Active
Acumed	80-1129	FDA UDI	Class I	Active
Acumed	SH-T4317	FDA UDI	Class II	Active
Acumed	PL-PHGL	FDA UDI	Class II	Active
Acumed	PL-ELCLR-S	FDA UDI	Class II	Active
Acumed	3016-40020-S	FDA UDI	Class II	Active
Acumed	ATM-160	FDA UDI	Class II	Active
Acumed	RL-3019-S	FDA UDI	Class II	Active
Acumed	3015-40026-S	FDA UDI	Class II	Active
Acumed	3005-73100-S	FDA UDI	Class II	Active
Acumed	3013-35014	FDA UDI	Class II	Active
Acumed	80-2218	FDA UDI	Class I	Active
Acumed	7001-0104L	FDA UDI	Class II	Active
Acumed	TR-TG01	FDA UDI	Class I	Active
Acumed	SH-2110	FDA UDI	Class I	Active
Acumed	HCA5600-S	FDA UDI	Class II	Active
Acumed	CO-T2342	FDA UDI	Class II	Active
Acumed	FA-4032	FDA UDI	Class II	Active
Acumed	COL-3280	FDA UDI	Class II	Active
Acumed	3006-73095-S	FDA UDI	Class II	Active
Acumed	80-0811	FDA UDI	Class I	Active
Acumed	71-0151	FDA UDI	Class II	Active
Acumed	PL-SA06L-S	FDA UDI	Class II	Active
Acumed	80-0959	FDA UDI	Class I	Active
Acumed	7001-0122L-S	FDA UDI	Class II	Active
Acumed	30-0304	FDA UDI	Class II	Active
Acumed	70-0004-S	FDA UDI	Class II	Unknown
Acumed	70-0035-S	FDA UDI	Class II	Active
Acumed	47-0018-S	FDA UDI	Class I	Active
Acumed	3701-1511N-S	FDA UDI	Class II	Active
Acumed	30-0315	FDA UDI	Class II	Active
Acumed	80-0484	FDA UDI	Class I	Active
Acumed	30-0021-S	FDA UDI	Class II	Active
Acumed	PL-DR65R-S	FDA UDI	Class II	Active
Acumed	HCA-5142	FDA UDI	Class II	Active
Acumed	3005-65090	FDA UDI	Class II	Active

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FDA Recalls (50)

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
Dec 19, 2023	Z-1218-2024	—	open, classified	Distribution without Pre-Market Clearance
Nov 27, 2023	Z-0618-2024	—	open, classified	Due to potential breakage during use.
Nov 29, 2022	Z-0769-2023	—	open, classified	Distribution without Pre-Market Clearance
Nov 29, 2022	Z-0767-2023	—	open, classified	Distribution without Pre-Market Clearance
Nov 29, 2022	Z-0768-2023	—	open, classified	Distribution without Pre-Market Clearance
Nov 29, 2022	Z-0770-2023	—	open, classified	Distribution without Pre-Market Clearance
Mar 9, 2022	Z-0959-2022	—	completed	Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Mar 9, 2022	Z-0958-2022	—	completed	Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Apr 20, 2017	Z-2197-2017	—	terminated	The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
Feb 17, 2017	Z-1483-2017	—	terminated	Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).
Jan 19, 2017	Z-1199-2017	—	terminated	The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed.
Dec 5, 2016	Z-1019-2017	—	terminated	OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification.
Mar 26, 2014	Z-1515-2014	—	terminated	Manufacturing of these devices with a grade of stainless steel that is not within specifications.
Mar 26, 2014	Z-1516-2014	—	terminated	Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
Mar 7, 2012	Z-1357-2012	—	terminated	The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates.
Apr 14, 2010	Z-1807-2010	—	terminated	The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union.
Aug 21, 2009	Z-0073-2010	—	terminated	Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385).
May 19, 2009	Z-1602-2010	—	terminated	Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
Aug 21, 2008	Z-1552-2010	—	terminated	Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.
Jul 9, 2008	Z-1154-2010	—	terminated	Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw.
May 13, 2008	Z-0447-2009	—	terminated	The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.
Mar 28, 2008	Z-2140-2008	—	terminated	Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.
Feb 14, 2008	Z-2127-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2110-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2112-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2131-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2130-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2111-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2128-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2114-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2119-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2129-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2115-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2108-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2126-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2120-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2124-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2121-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2123-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2113-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2125-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2117-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2122-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2118-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2109-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2116-2008	—	terminated	Product sterility may be compromised.
Feb 14, 2008	Z-2132-2008	—	terminated	Product sterility may be compromised.
Jul 9, 2007	Z-2135-2008	—	terminated	Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
Jun 29, 2007	Z-2153-2008	—	terminated	Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
Dec 27, 2005	Z-2155-2008	—	terminated	Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.