FDAFDA · Food and drugs·Recall number Z-1319-2024
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Published March 27, 2024 · Recall initiated: January 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- In2Bones, SAS
- Distributor
- US Nationwide distribution in the state of Tennessee.
- Lot
- UDI/DI 3760225710685, Batch Number 2306007, exp. 31/MAY/2028
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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