In2Bones recalls some Shannon Percutaneous Burrs (model G01 01511/01512) due to possible breakage during foot surgery, risking injury to patients.
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.
In2Bones is recalling specific models of Shannon Percutaneous Burrs that may break during surgery, potentially causing injury to patients. This recall affects medical devices used in foot procedures.
The burrs have a manufacturing defect that may cause them to break during use. This breakage could lead to injury to the patient's foot during surgery.
Medical professionals using these burrs for foot surgery are most at risk. Patients undergoing procedures with these specific models could face injury if the burr breaks.
Check for model numbers G01 01511 or G01 01512. Batches 2009139, 2001089, 2007087, and 2011062 are affected. These burrs are used for foot surgery procedures.
Identify if your burr is model G01 01511 or G01 01512.
Reach out to In2Bones for further guidance on the recall.
The recall is due to a manufacturing defect that may cause the burr to break during surgery.
Models G01 01511 and G01 01512, with specific batch numbers: 2009139, 2001089, 2007087, and 2011062.
Check for model numbers G01 01511 or G01 01512 and batch numbers listed in the recall.
We’ve drafted a message you can send In2Bones to request your refund or repair — edit it as you like.
Subject: Recall Z-1283-2021 — In2Bones In2Bones Hello, I own a In2Bones that is covered by recall Z-1283-2021 from In2Bones. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.