Facility

Acumed LLC -Brookwood Facility

10 recall(s) on record — most severe on record: Class II.

Key facts

10recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008396464
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	4860 NE Brookwood Parkway Hillsboro, OR, US 97124
Registration status	Active · expires 2026
Parent company	ACUMED LLC (owner-operator 9001805)
Brand names	Cutting Tool, Bit, Drill

Activity by year

Recalls (10)

Devices registered here (1)

Bit, Drill
Product code HTW (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IIOngoing2026-05-28
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Class IIOngoing2023-12-19
Distribution without Pre-Market Clearance
Class IIOngoing2023-11-27
Due to potential breakage during use.
Class IIOngoing2022-11-29
Distribution without Pre-Market Clearance
Class IICompleted2022-03-09
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.
Class IITerminated2017-04-20
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.
Class IITerminated2017-02-17
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 su…
Class IITerminated2017-01-19
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.
Class IITerminated2016-12-05
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.
Class IITerminated2014-03-26
Manufacturing of these devices with a grade of stainless steel that is not within specifications.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Acumed LLC -Brookwood Facility (FEI 3008396464) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008396464-acumed-llc-brookwood-facility/

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