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
|
|
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
|