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U.S. Department of Health and Human Services

Class 2 Device Recall In2Bones Shannon Percutaneous Burr

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 Class 2 Device Recall In2Bones Shannon Percutaneous Burrsee related information
Date Initiated by FirmFebruary 09, 2021
Create DateMarch 19, 2021
Recall Status1 Terminated 3 on July 11, 2024
Recall NumberZ-1283-2021
Recall Event ID 87341
Product Classification Bur, surgical, general & plastic surgery - Product Code GFF
ProductIn2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Code Information Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062
Recalling Firm/
Manufacturer		 In2Bones, SAS
28 Chemin du petit Bois
Ecully France
For Additional Information ContactMorgane GRENIER
33-0472-292626
Manufacturer Reason
for Recall		This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.
FDA Determined
Cause 2		Device Design
ActionA "FIELD CORRECTIVE ACTION MEDICAL DEVICE BATCH RECALL" and reply form dated 02/09/2021 were sent to customers.
Quantity in Commerce60 units
DistributionUS Nationwide distribution in the state of TN.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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