Acumed LLC
Acumed LLC appears in FDA public data with 15 recalls, 38 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2532-2026, Class II) was initiated on May 28, 2026. Its most recent 510(k) clearance was granted on August 21, 2025.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 38
- Inspections
- 4
- Compliance Actions
- 0
Known Names
acumed, acu-med
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2532-2026 | Class II | Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070- | May 28, 2026 |
| Z-1218-2024 | Class II | Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU | December 19, 2023 |
| Z-0618-2024 | Class II | RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile | November 27, 2023 |
| Z-0769-2023 | Class II | AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak | November 29, 2022 |
| Z-0770-2023 | Class II | Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Sc | November 29, 2022 |
| Z-0767-2023 | Class II | Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25 | November 29, 2022 |
| Z-0768-2023 | Class II | Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Ac | November 29, 2022 |
| Z-0958-2022 | Class II | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 | March 9, 2022 |
| Z-0959-2022 | Class II | 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 | March 9, 2022 |
| Z-2197-2017 | Class II | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic tra | April 20, 2017 |
| Z-1483-2017 | Class 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-1199-2017 | Class II | 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series | January 19, 2017 |
| Z-1019-2017 | Class II | OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of p | December 5, 2016 |
| Z-1515-2014 | Class II | The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 m | March 26, 2014 |
| Z-1516-2014 | Class II | The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in length | March 26, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | August 21, 2025 |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | July 14, 2025 |
| K251296 | The Acumed Wrist Fixation System | June 18, 2025 |
| K243624 | Acu-Sinch Knotless Mini | January 23, 2025 |
| K233311 | Acumed Wrist Plating System | April 22, 2024 |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | June 9, 2023 |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | December 29, 2022 |
| K212990 | Acumed Ankle Syndesmosis Repair System | January 7, 2022 |
| K210750 | Acumed Clavicle Hook Plating System | July 15, 2021 |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | October 30, 2015 |
| K143385 | Acumed Ankle Plating System | April 6, 2015 |
| K143276 | Acumed Small Bone IM Nail System | February 5, 2015 |
| K143394 | Acumed Small Fragment Base Set | January 23, 2015 |
| K141383 | ACUMED HAND FRACTURE SYSTEM | June 13, 2014 |
| K140925 | ACUMED SUTURE ANCHOR SYSTEM | May 20, 2014 |
| K133469 | ACUMED SUTURE ANCHOR SYSTEM | March 10, 2014 |
| K132769 | ACUMED HAND PLATING SYSTEM | January 6, 2014 |
| K131636 | POLARUS CONNECT | October 10, 2013 |
| K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC | September 30, 2013 |
| K131764 | ACUMED WRIST SPANNING PLATE | September 5, 2013 |