FDA recall Z-1319-2024

Product

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

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.

Distribution

US Nationwide distribution in the state of Tennessee.

Key facts

Status

Ongoing

Initiation date

2024-01-26

Report date

2024-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ecully, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1319-2024