Acumed Llc
5885 NE Cornelius Pass Rd, Hillsboro, OR, US
Registered product codes
31 product codes
Recent MDR events
6,148 on file
- 1.5mm Hex Driver Tip, Locking GrooveJul 27, 2026Malfunction3025141-2026-00365
- unknown screwJul 27, 2026Injury3025141-2026-00372
- 2.7MM X 12MM NON-LOCKING HEXALOBE SCREWJul 20, 2026Injury3025141-2026-00371
- 2.7MM X 16MM LOCKING HEXALOBE SCREWJul 20, 2026Injury3025141-2026-00368
- 3.5MM X 16MM LOCKING HEXALOBE SCREWJul 20, 2026Injury3025141-2026-00364
- UNKNOWN SCREWJul 17, 2026Injury3025141-2026-00367
- 2.7MM X 12MM NL HEXALOBE COCR SCREWJul 15, 2026Injury3025141-2026-00361
- 1.5MM HEX DRIVER TIP, LOCKING GROOVEJul 15, 2026Malfunction3025141-2026-00362
- T6 CANNULATED HEXALOBE DRIVERJul 15, 2026Malfunction3025141-2026-00370
- 2.7MM X 14MM NL HEXALOBE COCR SCREWJul 15, 2026Malfunction3025141-2026-00342
Recalls
51 on file
- Open, ClassifiedJun 23, 2026
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
View FDA record ↗ - Open, ClassifiedFeb 29, 2024
Distribution without Pre-Market Clearance
View FDA record ↗ - Open, ClassifiedDec 26, 2023
Due to potential breakage during use.
View FDA record ↗ - Open, ClassifiedDec 23, 2022
Distribution without Pre-Market Clearance
View FDA record ↗ - Open, ClassifiedDec 23, 2022
Distribution without Pre-Market Clearance
View FDA record ↗ - Open, ClassifiedDec 23, 2022
Distribution without Pre-Market Clearance
View FDA record ↗ - Open, ClassifiedDec 23, 2022
Distribution without Pre-Market Clearance
View FDA record ↗ - TerminatedMar 16, 2017
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).
View FDA record ↗ - TerminatedFeb 14, 2017
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.
View FDA record ↗ - TerminatedApr 25, 2014
Manufacturing of these devices with a grade of stainless steel that is not within specifications.
View FDA record ↗
Compliance history
Matched by FEI 1000125930.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.