Z-1319-2024Class II

I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

Name: Z-1319-2024 I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Creator: In2Bones, SAS
Published: 2024-01-26
License: https://open.fda.gov/license/

In2Bones SAS / initiated 2024-01-26 / Open, Classified / root cause: manufacturing process

FDA source

In2Bones, SAS began a recall of I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 on 2024-01-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1319-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-26
Posted: 2024-03-20
Recalling firm: In2Bones SAS
Product: I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 59 units
Distribution: US Nationwide distribution in the state of Tennessee.
Product codes and lots: UDI/DI 3760225710685, Batch Number 2306007, exp. 31/MAY/2028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1319-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-20
Z-1320-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-20

Product code HWC

K131920Class IIStabilization ScrewIn2bones Sas / cleared 2014-05-01

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)