Recall Z-1283-2021
In2Bones, SAS · initiated February 9, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Codes / lots: Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062
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.
FDA-determined cause: Device Design
Action taken
A "FIELD CORRECTIVE ACTION MEDICAL DEVICE BATCH RECALL" and reply form dated 02/09/2021 were sent to customers.
Details
- Recall number
- Z-1283-2021
- Initiated
- February 9, 2021
- Terminated
- July 11, 2024
- Product code
- GFF – Bur, Surgical, General & Plastic Surgery
- Quantity
- 60 units
- Distribution
- US Nationwide distribution in the state of TN.
- Recalling firm
- In2Bones, SAS, Ecully