FDAFDA · Food and drugs·Recall number Z-2127-2014
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.
Published August 6, 2014 · Recall initiated: May 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Small Bone Innovations
- Distributor
- Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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