In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Reported: March 31, 2021 Initiated: February 9, 2021 #Z-1283-2021
Product Description
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Reason for Recall
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.
Details
- Recalling Firm
- In2Bones, SAS
- Units Affected
- 60 units
- Distribution
- US Nationwide distribution in the state of TN.
- Location
- Ecully, N/A
Frequently Asked Questions
What product was recalled? ▼
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.. Recalled by In2Bones, SAS. Units affected: 60 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 31, 2021. Severity: Moderate. Recall number: Z-1283-2021.
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