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U.S. Department of Health and Human Services

Class 2 Device Recall Oxford/Oxbridge AFN End Cap

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  Class 2 Device Recall Oxford/Oxbridge AFN End Cap see related information
Date Initiated by Firm April 19, 2017
Create Date July 28, 2017
Recall Status1 Terminated 3 on March 19, 2019
Recall Number Z-2780-2017
Recall Event ID 77490
510(K)Number K121575  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Oxford/Oxbridge AFN End Cap
10 mm x 5 mm tp 12 mm x10 mm

The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
Code Information Item Code OS331107  S1009023 Mar-2017 S1009023 Mar-2017  Item Code OS331104 S1009020 Apr-2017  Item Code OS331100 995035 Aug-2017; Jan-2018  Item Code  OS331100 S1212114 May-2018  Item Code OS331101 S1009017 Jun-2018  Item Code OS331103 S1009019 Oct-2018  Item Code OS331105 S1102004 Oct-2018  Item Code OS331100 S1307176 Nov-2018, Dec-2018 S1401116 Apr-2019  Item Code OS331103 S1009019 May-2019  Item Code OS331105 S1102004 May-2019  Item Code OOS331100 7802 Oct-2019
Recalling Firm/
Manufacturer
Ortho Solutions Inc
330 Franklin Tpke
Mahwah NJ 07430-3524
Manufacturer Reason
for Recall
There is a material mislabeling of the AFN End Cap.
FDA Determined
Cause 2
Error in labeling
Action Orthosol notified their customers on 4/19/2017 via USPS.
Quantity in Commerce 277 units
Distribution US distribution to MD, NY & PA
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 = HSB and Original Applicant = ORTHO SOLUTIONS LIMITED
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