Reported Jun 11, 2014 · Terminated
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with…
Small Bone Innovations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Small Bone Innovations, Inc. · 1711 S Pennsylvania Ave · Morrisville, PA · 19067-2507
Is this the product you have?
- SBi RingFix Olive Wires Product UsageThese
- are temporary devices indicated forosteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy
- Lot codes and dates
item #451-3004lot V3R0R
- Amount recalled
- 44
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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