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.
FDA Recall Z-1720-2014 · Posted 2014-06-04
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Recalling FirmSmall Bone Innovations, Inc.
Recall StatusTerminated
Product CodeKTT
Date Initiated2014-04-07
Date Terminated2014-10-20
Product Quantity44
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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