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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: These are risk-of-harm surgical implant devices that were distributed without FDA pre-market clearance, meaning their safety and effectiveness were not validated by the FDA. While no illnesses or injuries have been reported, the widespread distribution of unvalidated orthopedic devices represents a significant potential risk.
Plain-English summary
Acumed LLC is recalling AcuTwist Acutrak Compression Screws in multiple sizes (10mm through 30mm). These orthopedic surgical devices are used in bone fixation procedures. Approximately 80,805 units were distributed.
The screws were distributed without FDA pre-market clearance, which is required before any medical device can be commercially distributed. Under FDA regulations, devices must receive clearance or approval demonstrating safety and effectiveness before being made available for commercial use.
The devices were distributed nationwide throughout the United States and to numerous international locations. Healthcare providers and patients who have undergone bone fixation surgeries may have received these uncleared devices.
Healthcare providers should verify any Acutrak Compression Screws in their inventory against the lot numbers listed in the FDA recall notice. Patients who have had orthopedic procedures involving these screws should contact their healthcare provider to discuss whether their implants were affected and determine appropriate follow-up care.
The recalled product
- 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
- Manufacturer
- Acumed LLC
- Hazard
- uncleared-device
- regulatory-non-compliance
Distribution
Distributed nationwide across the United States.
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