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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 2 of 139

Device	Model / Reference	Registries	Class	Status
Acumed	3006-40068	FDA UDI	Class II	Active
Acumed	20-0572-S	FDA UDI	Class II	Active
Acumed	50-0072-S	FDA UDI	Class II	Active
Acumed	70-0067	FDA UDI	Class II	Active
Acumed	3005-35034	FDA UDI	Class II	Active
Acumed	3040-23018	FDA UDI	Class II	Active
Acumed	CO-S2328-S	FDA UDI	Class I	Active
Acumed	CO-3320-S	FDA UDI	Class II	Active
Acumed	80-0266	FDA UDI	Class I	Active
Acumed	70-0171-S	FDA UDI	Class II	Active
Acumed	7206-3370N	FDA UDI	Class II	Active
Acumed	80-3926	FDA UDI	Class I	Active
Acumed	80-0392	FDA UDI	Class I	Active
Acumed	70-0097	FDA UDI	Class II	Active
Acumed	3003-43038-S	FDA UDI	Class II	Active
Acumed	30-0905	FDA UDI	Class II	Active
Acumed	3007-65105	FDA UDI	Class II	Active
Acumed	3005-73130-S	FDA UDI	Class II	Active
Acumed	TR-TH20R	FDA UDI	Class I	Active
Acumed	3007-65040	FDA UDI	Class II	Active
Acumed	3003-43022-S	FDA UDI	Class II	Active
Acumed	70-0110-S	FDA UDI	Class II	Active
Acumed	80-2092	FDA UDI	Class I	Active
Acumed	4011-3027N-S	FDA UDI	Class II	Active
Acumed	3050-20026	FDA UDI	Class II	Active
Acumed	70-0439-S	FDA UDI	Class II	Active
Acumed	80-1587	FDA UDI	Class I	Active
Acumed	3005-30019	FDA UDI	Class II	Active
Acumed	80-2499	FDA UDI	Class I	Active
Acumed	TR-S0900-S	FDA UDI	Class II	Active
Acumed	3007-65125-S	FDA UDI	Class II	Active
Acumed	FA-CO3516	FDA UDI	Class II	Active
Acumed	FA-0240-S	FDA UDI	Class II	Active
Acumed	80-2343	FDA UDI	Class I	Active
Acumed	30150106	FDA UDI	Class II	Active
Acumed	80-2365	FDA UDI	Class I	Active
Acumed	FA-CO2745-S	FDA UDI	Class II	Active
Acumed	46-0008-S	FDA UDI	Class II	Active
Acumed	SH-2005	FDA UDI	Class II	Unknown
Acumed	PL-LEL14R	FDA UDI	Class II	Active
Acumed	CO-T2332-S	FDA UDI	Class II	Active
Acumed	HCA-5155	FDA UDI	Class II	Active
Acumed	COL-3600-S	FDA UDI	Class II	Active
Acumed	AP-67015	FDA UDI	Class I	Active
Acumed	71-0011	FDA UDI	Class II	Active
Acumed	5101-0220R	FDA UDI	Class II	Active
Acumed	TR-H280R-S	FDA UDI	Class II	Active
Acumed	CO-N2344	FDA UDI	Class II	Active
Acumed	40-0137-S	FDA UDI	Class II	Active
Acumed	3006-40032-S	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.