I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
FDA device recall Z-1319-2024 · posted 2024-03-20 · Open, Classified
Recall details
- Recalling firm
- In2Bones, SAS
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HWC
- Quantity affected
- 59 units
- Distribution
- US Nationwide distribution in the state of Tennessee.
- Date initiated
- 2024-01-26
- Date posted
- 2024-03-20
- Location
- Ecully, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STABILIZATION SCREW (K131920) | In2bones Sas | 2014-05-01 |