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.
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: This is a Class II recall driven by regulatory non-compliance—distribution without FDA pre-market clearance—rather than a documented product defect or confirmed safety hazard. No illnesses or injuries are reported in the source. The recall addresses a compliance violation without established evidence of adverse product performance.
Plain-English summary
Acumed LLC is recalling Acutrak orthopedic implants, including various bone screws (4/5 Bone Screws, 6/7 Fixation Screws, Mini Acutrak models) and fusion devices ranging from 14mm to 37mm. Approximately 306,934 units are affected by this recall.
The devices were distributed without obtaining required FDA pre-market clearance. Pre-market clearance is required to establish and verify a medical device's safety and effectiveness before it is marketed in the United States.
The recalled devices were distributed worldwide, including across all U.S. states and internationally to multiple countries. Specific affected products are identified by their part numbers and UDI codes detailed in FDA records.
Patients who have received these implants should consult with their healthcare provider regarding potential implications. Healthcare facilities with affected inventory should contact Acumed LLC for further instructions.
The recalled product
- 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
- Manufacturer
- Acumed LLC
- Hazard
- regulatory-non-compliance
Distribution
Distributed nationwide across the United States.
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