Recall Z-1320-2024— In2Bones, SAS
Class II · Ongoing
Class II FDA medical device recall by In2Bones, SAS, initiated 2024-01-26. It names one FDA 510(k) clearance: K131920. Product: I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180. 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..
- Recalling firm
- In2Bones, SAS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-26
- Firm location
- Ecully, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.