Date Initiated by Firm | March 09, 2015 |
Date Posted | March 25, 2015 |
Recall Status1 |
Terminated 3 on May 19, 2016 |
Recall Number | Z-1319-2015 |
Recall Event ID |
70736 |
510(K)Number | K132912 |
Product Classification |
Screw, fixation, bone - Product Code HWC
|
Product | DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only.
Interphalangeal implant. |
Code Information |
Batch numbers: 1412021 |
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 | 15 units |
Distribution | Distributed in the state of TN. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = HWC
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