Product Safety Recalls

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In2Bones, SAS Recall 87341

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

In2Bones, SAS Recall 87341 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1283-2021
Event ID87341
Event DescriptionIn2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Product TypeDevices
DistributionUS Nationwide distribution in the state of TN.
Quantity60 units
Recall ReasonThis 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.
Device Classification20210331
Device Code InfoModel G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062
Center Classification Date20210319
Recall Initiation Date20210209
Recalling FirmIn2Bones, SAS
Initial Notification E-Mail
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