In2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use
In2Bones is recalling 60 units of Shannon Percutaneous Burrs due to manufacturing non-conformity that may cause the burr to break during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of breakage during surgery, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
In2Bones, SAS is recalling 60 units of Shannon Percutaneous Burrs (diameter 2.0mm, length 20mm) due to a manufacturing non-conformity. The affected products are indicated for forefoot mini-invasive and percutaneous surgery.
The recall was initiated because the manufacturing defect may cause the burr to break during use. The specific models and batches involved are Model G01 01511 (Batches 2009139 and 2001089) and Model G01 01512 (Batches 2007087 and 2011062).
The products were distributed nationwide in the state of Tennessee. Healthcare providers and facilities that have received these specific units should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
- Manufacturer
- In2Bones, SAS
- Hazard
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model G01 01511
- Batches 2009139 and 2001089 Model G01 01512
- Batches 2007087 and 2011062
Distribution
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