Ecully, France
In2Bones, SAS recalls
2 recalls recorded since 2018, most recently on 26 January 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 January 2024
- Reason
- This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
- Distribution
- US Nationwide distribution in the state of Tennessee.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1320-2024, Z-1319-2024
- I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
- I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Terminated Class II Medical devices
- Recall started
- 9 February 2021
- Terminated
- 11 July 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1283-2021
- In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.