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Recall Observatory FDA recall evidence

Device product

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

Z-1283-2021

February 09, 2021

Class II

Product summary

Firm
In2Bones, SAS
Event
Event 87341
Status
Terminated
Classification
Class II
Quantity
60 units
Official record key
device-enforcement:Z-1283-2021

Official wording

Reason: 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.

Code information: Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062

Distribution pattern: US Nationwide distribution in the state of TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.