Reported Jun 11, 2014 · Terminated

SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with…

Small Bone Innovations, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Small Bone Innovations, Inc. · 1711 S Pennsylvania Ave · Morrisville, PA · 19067-2507

Is this the product you have?

  • SBi RingFix Olive Wires Product UsageThese
  • are temporary devices indicated forosteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy
Lot codes and dates
    • item #451-3004
    • lot V3R0R
Amount recalled
44

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Small Bone Innovations, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 20, 2014 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.