In2Bones, SAS recalls I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

Recall date

January 26, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1319-2024

FDA classification

Class II

Brand / firm

In2Bones, SAS

Sold / distributed

US Nationwide distribution in the state of Tennessee.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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