FDA Medical Device Recalls (openFDA)
In2Bones, SAS: I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
- Recall number
- Z-1319-2024
- Recalling firm
- In2Bones, SAS
- Product
- I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
- Status
- Open, Classified
- Initiated
- 2024-01-26
- Posted
- 2024-03-20
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI/DI 3760225710685, Batch Number 2306007, exp. 31/MAY/2028
- 510(k) numbers
- ["K131920"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3010470577
- Firm city
- Ecully
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28