The Recall Desk

Manufacturer

Acumed LLC

15 recalls in our database name Acumed LLC as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
0
Most recent
2026-07-01

Of the 15 recalls from Acumed LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

  • HighFDA (Devices)·Z-2532-2026·2026-07-01

    Acumed Hexalob Screws Recalled for Risk of Fracture During Use

    Acumed LLC is recalling Hexalob Screws of various sizes used with wrist fixation systems due to a manufacturing error that may cause the screws to break during use.

    Product
    Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw; 3070-27013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2024·2024-03-06

    Bone plates and surgical screws distributed without FDA pre-market clearance

    Acumed LLC is recalling 2,952,121 units of Acu-Loc bone plates, screws, and accessories distributed worldwide because they were placed on the market without FDA pre-market clearance. The safety and effectiveness of these devices have not been verified by the FDA.

    Product
    Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2024·2024-01-03

    Acumed RibLoc U Plus 90 Surgical Guide Recalled for Potential Breakage

    Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.

    Product
    RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2023·2023-01-04

    Orthopedic Compression Screws Distributed Without FDA Pre-Market Clearance

    Acumed LLC recalled AcuTwist Acutrak Compression Screws (80,805 units) distributed without FDA pre-market clearance. The devices lack FDA evaluation for safety and effectiveness.

    Product
    AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2023·2023-01-04

    Dual-Trak Clavicle Screws recalled: distributed without FDA pre-market clearance

    Acumed LLC is recalling 7,498 units of Dual-Trak Clavicle Screws distributed worldwide without FDA pre-market clearance. These orthopedic surgical screws were marketed without required regulatory approval.

    Product
    Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0768-2023·2023-01-04

    Acumed Acutrak 2 Bone Screws Recalled for Distribution Without FDA Clearance

    Acumed is recalling Acutrak 2 bone screw products distributed without FDA pre-market clearance. Healthcare providers should contact Acumed or the FDA for guidance regarding use and management of these devices.

    Product
    Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0767-2023·2023-01-04

    Acutrak Bone Screws and Fusion Devices Recalled for Lack of FDA Pre-Market Clearance

    Acumed LLC is recalling Acutrak bone screws and fusion devices distributed without FDA pre-market clearance. Patients should contact their healthcare provider for guidance.

    Product
    Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S 45.0mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0958-2022·2022-04-27

    Acumed Cannulated Screws May Lack Sufficient Strength for Bone Fixation

    Acumed 4.0mm x 10mm Cannulated Screws may not have sufficient strength to hold bone fragments in place. This could result in improper bone healing, fracture, or soft tissue damage.

    Product
    4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2022·2022-04-27

    Acumed Cannulated Screws Recalled for Insufficient Axial Pullout Strength

    Acumed LLC is recalling Cannulated Screws (4.0mm x 12mm) that may not have sufficient strength to hold bone fragments together, risking fracture or joint damage.

    Product
    4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2017·2017-06-07

    Acumed Recalls Slide-Loc Anatomic Radial Head System Due to Performance Issues

    Acumed LLC is voluntarily removing the Slide-Loc Anatomic Radial Head System from the market due to complaints about instrumentation performance, trial design, and implant dissociations.

    Product
    The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2017·2017-03-22

    Acumed Orthopedic Guide Wires Recalled Due to Packaging Errors

    Acumed LLC is recalling specific lots of .045 and .054 orthopedic guide wires because they were mis-packaged with incorrect size labels.

    Product
    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1199-2017·2017-02-22

    Acumed Recalls 6-Hole Pubic Symphysis Plates Due to Material Error

    Acumed LLC is recalling 15 units of 6-hole Pubic Symphysis plates because they were manufactured with the wrong titanium alloy.

    Product
    6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured wher
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1019-2017·2017-01-18

    Acumed Recalls OPT Croutons Synthetic Bone Substitute Due to Sterilization Documentation Issues

    Acumed LLC is recalling 83 units of OPT Croutons synthetic bone substitute because documentation for the sterilization dose was inadequate. The product was distributed in ten US states and Puerto Rico.

    Product
    OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1516-2014·2014-05-07

    Acumed Recalls Tension Band Pins Due to Steel Specification Defect

    Acumed LLC is recalling specific lots of Tension Band Pins because they were manufactured with stainless steel that does not meet specifications.

    Product
    The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2014·2014-05-07

    Acumed Osteo-Clage System Recalled for Non-Specification Stainless Steel

    Acumed LLC is recalling the Osteo-Clage System because the stainless steel used in manufacturing was not within specifications.

    Product
    The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression p
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Acumed

Country
United States
Founded
1988

Official website

Source: Wikidata (Q4677880), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.