Device product
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Z-1320-2024
Product summary
- Firm
- In2Bones, SAS
- Event
- Event 94063
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 63 units
- Official record key
device-enforcement:Z-1320-2024
Official wording
Reason: 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.
Code information: UDI/DI 3760225710692, Batch Number 2306008, exp. 31/MAY/2028
Distribution pattern: US Nationwide distribution in the state of Tennessee.
Derived failure modes
-
Unknown
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.