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ACUMED LLC

Last updated September 17, 2026

What ACUMED LLC makes

Acumed LLC manufactures orthopaedic bone screws, non-bioabsorbable fixation plates, and general internal orthopaedic fixation system implantation kits. The company also produces reusable bone taps and various sterile and non-sterile internal fixation systems consisting of plate and screw combinations.

The company is based in the United States, and its portfolio of Class I and Class II medical devices is listed in the FDA UDI database.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

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

Catalogue (6937)

Page 90 of 139

Device	Model / Reference	Registries	Class	Status
Acumed	FA-9020	FDA UDI	Class I	Active
Acumed	70-0343	FDA UDI	Class II	Unknown
Acumed	30-0304-S	FDA UDI	Class II	Active
Acumed	80-0304	FDA UDI	Class I	Active
Acumed	80-0387	FDA UDI	Class I	Active
Acumed	80-0519	FDA UDI	Class I	Active
Acumed	70-0019	FDA UDI	Class II	Active
Acumed	3004-15007-S	FDA UDI	Class II	Active
Acumed	80-4198	FDA UDI	Class I	Active
Acumed	20-0184	FDA UDI	Class II	Active
Acumed	3005-30029	FDA UDI	Class II	Active
Acumed	30100340	FDA UDI	Class II	Active
Acumed	80-1884	FDA UDI	Class I	Active
Acumed	CO-N2342-S	FDA UDI	Class II	Active
Acumed	30-0267-S	FDA UDI	Class II	Active
Acumed	75-0045	FDA UDI	Class II	Active
Acumed	3040-23010-S	FDA UDI	Class II	Active
Acumed	80-2079	FDA UDI	Class I	Active
Acumed	70-0388	FDA UDI	Class II	Active
Acumed	SH-5123-S	FDA UDI	Class I	Active
Acumed	E-TR-BRA075	FDA UDI	Class I	Active
Acumed	80-1154	FDA UDI	Class I	Active
Acumed	CO-T2340	FDA UDI	Class II	Active
Acumed	3013-35040	FDA UDI	Class II	Active
Acumed	3004-15009-S	FDA UDI	Class II	Active
Acumed	CO-3060	FDA UDI	Class II	Active
Acumed	55-0001-S	FDA UDI	Class I	Active
Acumed	3005-40052	FDA UDI	Class II	Active
Acumed	30-0510	FDA UDI	Class II	Active
Acumed	80-1706	FDA UDI	Class I	Active
Acumed	30-0025	FDA UDI	Class II	Active
Acumed	70-0121-S	FDA UDI	Class II	Active
Acumed	70-0358	FDA UDI	Class II	Active
Acumed	80-1723	FDA UDI	Class II	Unknown
Acumed	3007-73135	FDA UDI	Class II	Active
Acumed	3006-30019	FDA UDI	Class II	Active
Acumed	80-2531	FDA UDI	Class I	Active
Acumed	80-2126	FDA UDI	Class I	Active
Acumed	AP-6775-S	FDA UDI	Class II	Active
Acumed	80-1531	FDA UDI	Class I	Active
Acumed	PL-VO47-S	FDA UDI	Class II	Unknown
Acumed	71-0429	FDA UDI	Class II	Active
Acumed	TR-H240L-S	FDA UDI	Class II	Active
Acumed	7008-0108-S	FDA UDI	Class II	Active
Acumed	TR-TH28L	FDA UDI	Class I	Active
Acumed	E-40-0092	FDA UDI	Class II	Active
Acumed	80-2214	FDA UDI	Class II	Unknown
Acumed	TR-TGA06	FDA UDI	Class II	Active
Acumed	30-0359-S	FDA UDI	Class II	Active
Acumed	7014-0512L	FDA UDI	Class II	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 (50)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 50 recall records for Acumed LLC initiated between December 27, 2005, and December 19, 2023, with statuses recorded as completed, open, classified, and terminated. The reasons provided for these recalls include labeling and packaging errors, the use of stainless steel grades outside of specifications, potential breakage, product sterility concerns, instrumentation performance, and distribution without pre-market clearance.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.