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Small Bone Innovations recalls Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indi
Recalled August 6, 2014 · FDA recall Z-2127-2014 · Small Bone Innovations
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. · FDA Class II
Units
506
Sold at
Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.
Description
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.
Product
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.
Manufacturer(s)
Small Bone Innovations
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →