Reported Mar 31, 2021 · Terminated

In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.

In2Bones, SAS

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: In2Bones, SAS · 28 Chemin du petit Bois · Ecully, N/A · N/A

Is this the product you have?

  • In2Bones Shannon
  • Percutaneous Burr - Product Usageindicated for forefoot mini-invasive and percutaneous surgery
Lot codes and dates
    • Model G01 01511
    • Batches 2009139 and 2001089 Model G01 01512
    • Batches 2007087 and 2011062
Amount recalled
60 units

Where it was sold

  • Nationwide
  • TN

Why it was recalled

This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 11, 2024 · Data as of Sep 19, 6:58 PM UTC

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