Recall Z-1319-2024 ยท HWC Screw, Fixation, Bone
In2Bones, SAS
I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
| Date | Mar 20, 2024 (initiated Jan 26, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 59 units |
| Distribution | US Nationwide distribution in the state of Tennessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131920 | STABILIZATION SCREW In2bones Sas, May 1, 2014 |