Recall Z-1720-2014 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Small Bone Innovations, Inc.
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.
| Date | Jun 4, 2014 (initiated Apr 7, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Packaging process control |
| Action | SBi sent an Urgent Medical Device Recall dated April 7, 2014, to affected customers (sales consultants, distributors, and end users). The letter identified the affected product, problem and actions to be taken. For questions call 215-428-1791 ext 248. |
| Quantity | 44 |
| Distribution | US Nationwide Distribution in the states of IN, NC, WA, NH, and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071394 | MODIFICATION TO:SBI RINGFIX Small Bone Innovations, Inc., Jun 29, 2007 |