Acumed LLC

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
38
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1218-2024Class IIAcu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDUDecember 19, 2023
Z-0618-2024Class IIRibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile November 27, 2023
Z-0769-2023Class IIAcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ AcutrakNovember 29, 2022
Z-0767-2023Class IIPart Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25November 29, 2022
Z-0768-2023Class IIAcutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm AcNovember 29, 2022
Z-0770-2023Class IIDual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle ScNovember 29, 2022
Z-0959-2022Class II4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012March 9, 2022
Z-0958-2022Class II4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010March 9, 2022
Z-2197-2017Class IIThe Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic traApril 20, 2017
Z-1483-2017Class II.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length February 17, 2017
Z-1199-2017Class II6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series January 19, 2017
Z-1019-2017Class IIOPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pDecember 5, 2016
Z-1515-2014Class IIThe Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mMarch 26, 2014
Z-1516-2014Class IIThe Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengthMarch 26, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAugust 21, 2025
K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsJuly 14, 2025
K251296The Acumed Wrist Fixation SystemJune 18, 2025
K243624Acu-Sinch Knotless MiniJanuary 23, 2025
K233311Acumed Wrist Plating SystemApril 22, 2024
K230744Acumed Acutrak 3 Headless Compression Screw SystemJune 9, 2023
K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalDecember 29, 2022
K212990Acumed Ankle Syndesmosis Repair SystemJanuary 7, 2022
K210750Acumed Clavicle Hook Plating SystemJuly 15, 2021
K151886Acumed Ankle and Small Fragment Base Set UpdateOctober 30, 2015
K143385Acumed Ankle Plating SystemApril 6, 2015
K143276Acumed Small Bone IM Nail SystemFebruary 5, 2015
K143394Acumed Small Fragment Base SetJanuary 23, 2015
K141383ACUMED HAND FRACTURE SYSTEMJune 13, 2014
K140925ACUMED SUTURE ANCHOR SYSTEMMay 20, 2014
K133469ACUMED SUTURE ANCHOR SYSTEMMarch 10, 2014
K132769ACUMED HAND PLATING SYSTEMJanuary 6, 2014
K131636POLARUS CONNECTOctober 10, 2013
K131845ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOCSeptember 30, 2013
K131764ACUMED WRIST SPANNING PLATESeptember 5, 2013