In2Bones Shannon Percutaneous Burr - Product Usage recall
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Why was In2Bones Shannon Percutaneous Burr - Product Usage 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062
- Product
- In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
- Recalling firm
- In2Bones, SAS
- Quantity
- 60 units
- Distribution
- US Nationwide distribution in the state of TN.
- Recall date
- March 31, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)