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Small Bone Innovations Recalls
3 recalls on record · November 6, 2013 to August 6, 2014 · Medical Devices
Recalls by year
13
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 6, 2014Medical DevicesFDA
Small Bone Innovations recalls Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indi
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.
June 11, 2014Medical DevicesFDA
Small Bone Innovations, Inc. recalls SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with s
Hazard: Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside.
November 6, 2013Medical DevicesFDA
Small Bone Innovations, Inc. recalls Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Rad
Hazard: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.