FDAFDA · Food and drugs·Recall number Z-1720-2014
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.
Published June 11, 2014 · Recall initiated: April 7, 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 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Small Bone Innovations, Inc.
- Distributor
- US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
- Lot
- item #451-3004, lot V3R0R.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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