Z-1319-2024 Class II Ongoing
FDA device recall Z-1319-2024 was initiated by In2Bones, SAS on January 26, 2024 and is designated Class II. 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 recall status is ongoing. Affected quantity: 59 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2024
- Initiation Date
- January 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units
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.
Distribution Pattern
US Nationwide distribution in the state of Tennessee.
Code Information
UDI/DI 3760225710685, Batch Number 2306007, exp. 31/MAY/2028