In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
This recall has been terminated (originally issued February 9, 2021).
- Recall Initiated
- February 9, 2021
- Terminated
- July 11, 2024
- Recall Number
- Z-1283-2021
- Quantity
- 60 units
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the state of TN.
Lot / Code Info
Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062
Root Cause
Device Design
Action Taken
A "FIELD CORRECTIVE ACTION MEDICAL DEVICE BATCH RECALL" and reply form dated 02/09/2021 were sent to customers.
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