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Open, Classified

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

FDA Recall Z-1319-2024 · Posted 2024-03-20

Recalling FirmIn2Bones, SAS
Recall StatusOpen, Classified
Product CodeHWC
Date Initiated2024-01-26
Product Quantity59 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of Tennessee.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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