I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
This recall is currently active, issued March 20, 2024. It was issued by In2Bones, Sas 28 Chemin Du Petit Bois Ecully France.
- Recall Initiated
- January 26, 2024
- Posted
- March 20, 2024
- Recall Number
- Z-1320-2024
- Quantity
- 63 units
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
UDI/DI 3760225710692, Batch Number 2306008, exp. 31/MAY/2028
Root Cause
Process control
Action Taken
The firm notified its US consignee via email on 02/26/2024. The email identified the products begin recalled and attached the notice the consignee was to use to notify their customers. That notice, the FIELD CORRECTIVE ACTION, MEDICAL DEVICE BATCH RECALL - EXTENSION, was issued on 01/26/2024, via email, to the US consignees which explained the issue with the device, associated risks, and requested the return of the affected products.