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Recall Observatory FDA recall evidence

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

April 07, 2014

Class II

Product summary

Firm
Small Bone Innovations, Inc.
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

    reason.no_named_rule · v1.0.0

    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.