IBS recallZ-1319-2024 · In2Bones, SAS · initiated Jan 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from In2Bones, SAS or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1319-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 26, 2024
- Posted by the FDA
- Mar 20, 2024
- Recalling firm
- In2Bones, SAS
- Quantity
- 59 units
- Product code
- HWC
- FDA submissions
- K131920
- Distribution
- US Nationwide distribution in the state of Tennessee.
Product description
I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Code information (models, lots, serial numbers)
UDI/DI 3760225710685, Batch Number 2306007, exp. 31/MAY/2028
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IBS™ S65 ST175In2bones · Screw, Fixation, Bone1 recall0 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K131920 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- IBS™ S65 ST180In2bones · Screw, Fixation, Bone1 recall0 reports
- IBS™ S25 ST028In2bones · Screw, Fixation, Bone2 reports
- IBS™ S25 ST022In2bones · Screw, Fixation, Bone1 report
- IBS™ S25 ST024In2bones · Screw, Fixation, Bone1 report
- IBS™ S35 ST132In2bones · Screw, Fixation, Bone1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 94063).
- Z-1320-2024 · Open, ClassifiedI.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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