PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 27, 2024 Initiated: January 26, 2024 #Z-1319-2024

Product Description

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.

Details

Recalling Firm
In2Bones, SAS
Units Affected
59 units
Distribution
US Nationwide distribution in the state of Tennessee.
Location
Ecully

Frequently Asked Questions

What product was recalled?
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175. Recalled by In2Bones, SAS. Units affected: 59 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1319-2024.