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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II classification warrants moderate severity level. However, no adverse events, injuries, or product safety defects are reported in the recall notice. The recall addresses regulatory non-compliance (lack of pre-market clearance) rather than an identified safety hazard.
Plain-English summary
Acumed LLC is recalling Acutrak 2 bone screws and related variants (including Micro Acutrak 2) that were distributed without obtaining FDA pre-market clearance. The recalled products include multiple screw sizes (20mm to 120mm length) in three diameter variants (4.7mm, 5.5mm, and 7.5mm) across numerous part numbers and batch codes. Approximately 1.68 million units were distributed.
The recall was initiated because these orthopedic implants were distributed in the United States and internationally (to more than 35 countries) without FDA pre-market approval prior to distribution. This is a regulatory compliance issue. No specific product defect or safety hazard has been identified in the source recall notice.
The devices were distributed nationwide across all U.S. states and territories, and internationally to countries including Australia, Canada, Japan, Germany, United Kingdom, France, and many others.
Healthcare providers and facilities that have used or possess these devices should contact Acumed LLC or the FDA for guidance on appropriate management and next steps regarding these devices.
The recalled product
- 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
- Manufacturer
- Acumed LLC
- Hazard
- distribution-without-fda-clearance
Distribution
Distributed nationwide across the United States.
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