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U.S. Department of Health and Human Services

Class 2 Device Recall I.B.S. orthosynthesis screws

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  Class 2 Device Recall I.B.S. orthosynthesis screws see related information
Date Initiated by Firm November 18, 2015
Date Posted December 09, 2015
Recall Status1 Terminated 3 on August 19, 2016
Recall Number Z-0397-2016
Recall Event ID 72711
510(K)Number K131920  
Product Classification Screw, fixation, bone - Product Code HWC
Product IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Code Information 1509058
Recalling Firm/
Manufacturer		 In2Bones, SAS
28 Chemin Du Petit Bois
Ecully France
Manufacturer Reason
for Recall		 One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action IN2Bones - USA sent an Field Safety Corrective Action Medical Device Batch Recall letter dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recommended actions : We therefore you to follow the instructions here below: 1. Identify all I.B.screws with the batches subject of this recall that might still be in your inventory and quarantine them 2. Inform and distribute this Recall Notification to all relevant persons within your organization 3. To distributors only : Identify all I.B.screws with the batches subject of this recall that were delivered to your customers, and if relevant instruct them to also follow these instructions (identification and quarantine) 4. Fill in and return the fax back form enclosed. With this form, you will certify that you have received this Recall Notification and intend to, comply with the recommendations listed.This fax back form will enable ln2Bones to conduct effectiveness checks. For any question,plea1se contact our Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +33 7 6188 44 30 or by email:qualite@in2bones.com.
Quantity in Commerce 20 units
Distribution US Distribution to the state of :TN
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = IN2BONES SAS
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