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.
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: FDA Class II device recall with no reported illnesses or injuries. The product was distributed without required FDA pre-market clearance, constituting a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Acumed LLC is recalling Dual-Trak Clavicle Screws, orthopedic surgical screws used in clavicle fracture repairs. The recall affects multiple part numbers (40-0136 through 40-0147 and -S variants) in 3.0mm and 3.8mm diameters ranging from 80mm to 120mm in length. Approximately 7,498 units were involved in this recall.
The screws were distributed to the United States and internationally without FDA pre-market clearance. FDA pre-market clearance is legally required before medical devices can be marketed in the United States, and this product did not obtain that approval prior to distribution.
Distribution was nationwide across all U.S. states and territories, as well as to multiple countries internationally. Healthcare facilities, surgeons, and hospitals that received these screws should be aware of this recall status.
Patients with implanted screws and healthcare providers should contact Acumed LLC for recall instructions. Any unused screws should be segregated pending further instructions from the manufacturer. Surgeons should determine appropriate follow-up actions for patients with previously implanted devices.
The recalled product
- 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
- Manufacturer
- Acumed LLC
- Hazard
- unapproved-distribution
- missing-regulatory-clearance
Distribution
Distributed nationwide across the United States.
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