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U.S. Department of Health and Human Services

Class 2 Device Recall DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002

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  Class 2 Device Recall DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002 see related information
Date Initiated by Firm March 09, 2015
Date Posted March 25, 2015
Recall Status1 Terminated 3 on May 19, 2016
Recall Number Z-1318-2015
Recall Event ID 70736
510(K)Number K132912  
Product Classification Screw, fixation, bone - Product Code HWC
Product DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only.

Interphalangeal implant.
Code Information Batch numbers: 1404032, 1412011
Recalling Firm/
Manufacturer		 In2Bones, SAS
28 Chemin Du Petit Bois
Ecully France
Manufacturer Reason
for Recall		 Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm notified their sole consignee in the US by email on 03/09/2015 requesting the return of the product, and to notify his consignee(s) to quarantine the unused product.
Quantity in Commerce 35 units
Distribution Distributed in 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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