Device product
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.
Z-1720-2014
Product summary
- Event
- Event 68039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44
- Official record key
device-enforcement:Z-1720-2014
Official wording
Reason: 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.
Code information: item #451-3004, lot V3R0R.
Distribution pattern: US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
Derived failure modes
-
Unknown
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.