FDAClass IIMarch 27, 2024

I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm recall

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

Why was I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 3760225710685, Batch Number 2306007, exp. 31/MAY/2028

Product
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Recalling firm
In2Bones, SAS
Quantity
59 units
Distribution
US Nationwide distribution in the state of Tennessee.
Recall date
March 27, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls