The Recall Desk

FDA (Devices) recall action 90996

Acumed LLC recalled 4 products on 2023-01-04

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2023-01-04
Critical
0
Units
88,303

Why these products were recalled

Distribution without Pre-Market Clearance

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··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
    Distribution
    53 states
  • HighFDA (Devices)··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
    Distribution
    53 states
  • HighFDA (Devices)··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
    Distribution
    53 states
  • ModerateFDA (Devices)··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
    Distribution
    53 states