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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 139 of 139

Device	Model / Reference	Registries	Class	Status
Fixation Pins/Wires	K943856	FDA 510(k)	Class II	Active
Acumed Wrist Arthrodesis Plate System	K100123	FDA 510(k)	Class II	Active
Acumed Suture Anchor System	K133469	FDA 510(k)	Class II	Active
Acumed Small Bone IM Nail System	K143276	FDA 510(k)	Class II	Active
Frag-Loc System	K130986	FDA 510(k)	Class II	Active
Osteo-Clage(tm) Cerciage Cable System	K921480	FDA 510(k)	Class II	Active
Trochanter Mesh	K945027	FDA 510(k)	Class II	Active
Acumed Carpal Tunnel Release Kit	K933638	FDA 510(k)	Class II	Active
Huene Fixation Screw	K910193	FDA 510(k)	Class II	Active
External Fixator	K952330	FDA 510(k)	Class II	Active
Acumed Small Fragment Base Set	K143394	FDA 510(k)	Class II	Active
Bone Plate System	K942359	FDA 510(k)	Class II	Active
Acumed Rib Congrient Bone Plate System	K051410	FDA 510(k)	Class II	Active
Congruent Bone Plate System: Acu-Loc 2 Plate	K120903	FDA 510(k)	Class II	Active
Acu-Sinch Knotless Mini	K243624	FDA 510(k)	Class II	Active
Gts Great Toe System - (metatarsal Component With Porous Coating)	K950864	FDA 510(k)	U	Active
Acumed Radius Rod	K933361	FDA 510(k)	Class II	Active
Acutrak Plus Fixation System	K944330	FDA 510(k)	Class II	Active
Tentatively Polarus Ex Rod	K952534	FDA 510(k)	Class II	Active
Extremity Bone Screw	K963118	FDA 510(k)	Class II	Active
Rod, Fixation, Intramedullary And Accessories	K951673	FDA 510(k)	Class II	Active
Acumed Small Bone Locking Rod System Ii	K031438	FDA 510(k)	Class II	Active
Bone Screw 3.5 Mm	K915613	FDA 510(k)	Class II	Active
Acumed Hand Plating System	K132769	FDA 510(k)	Class II	Active
Great Toe Implant	K920667	FDA 510(k)	U	Active
Bone Fixation Nail	K943855	FDA 510(k)	Class II	Active
Acumed Scapula Congruent Bone Plate System	K051083	FDA 510(k)	Class II	Active
Intramedulary Fixation Rod	K951740	FDA 510(k)	Class II	Active
The Acumed Wrist Fixation System - 2.4mm Screws	K252356	FDA 510(k)	Class II	Active
Acumed Wrist Plating System	K233311	FDA 510(k)	Class II	Active
Acumed Lower Extremity Congruent Plate System	K033639	FDA 510(k)	Class II	Active
Acumed Totalw Rist Fusion Plating System	K131380	FDA 510(k)	Class II	Active
Bone Screw Washer	K943782	FDA 510(k)	Class II	Active
Orthopaedic Wires	K942603	FDA 510(k)	Class II	Active
Acumed Clavicle Screw System	K083144	FDA 510(k)	Class II	Active
Acumed Congruent Bone Plate System	K063460	FDA 510(k)	Class II	Active
Acumed Ankle and Small Fragment Base Set Update	K151886	FDA 510(k)	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.