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U.S. Department of Health and Human Services

Class 2 Device Recall In2Bones

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 Class 2 Device Recall In2Bonessee related information
Date Initiated by FirmJanuary 26, 2024
Date PostedMarch 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1319-2024
Recall Event ID 94063
510(K)NumberK131920 
Product Classification Screw, fixation, bone - Product Code HWC
ProductI.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Code Information UDI/DI 3760225710685, Batch Number 2306007, exp. 31/MAY/2028
Recalling Firm/
Manufacturer		 In2Bones, SAS
28 Chemin du petit Bois
Ecully France
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionThe firm notified its US consignee via email on 02/26/2024. The email identified the products begin recalled and attached the notice the consignee was to use to notify their customers. That notice, the FIELD CORRECTIVE ACTION, MEDICAL DEVICE BATCH RECALL - EXTENSION, was issued on 01/26/2024, via email, to the US consignees which explained the issue with the device, associated risks, and requested the return of the affected products.
Quantity in Commerce59 units
DistributionUS Nationwide distribution in the state of Tennessee.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HWC
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