Z-1720-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2014
- Initiation Date
- April 7, 2014
- Termination Date
- October 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
Code Information
item #451-3004, lot V3R0R.